(APA, 2020)
Most University of North Alabama students completed the program within 2 years (2018)
(University of North Alabama, 2018)
Ice cream is highly correlated with happiness according to studies by A. Kramer and B. Kramer (2005)
(A. Kramer & B. Kramer, 2005)
Cane later duplicated these results in another study (2013)
(Cane, 2013)
Cane successfully duplicated these results (2012a)
(Cane, 2012a)
(Cane, 2012b)
(Cox, 1989; McGee 2011; Shaffer et al., 2019)
Once again, if grammar isn’t your thing, and you’re looking for help related to specific parts of speech, check out our adjective , pronoun , and determiner pages, among many, many others!
Follow our EasyBib Twitter feed to find more citing tips, fun grammar facts, and the latest product updates.
American Psychological Association. (2020). Publication manual of the American Psychological Association (7th ed.) https:doi.org/10.1037/0000165-000
Published May 21, 2019. Updated October 25, 2020.
Written and edited by Michele Kirschenbaum and Elise Barbeau . Michele Kirschenbaum is a school library media specialist and one of the in-house EasyBib librarians. Elise Barbeau is the Citation Specialist at Chegg. She has worked in digital marketing, libraries, and publishing.
APA Formatting
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An in-text citation is a shortened version of the source being referred to in the paper. As the name implies, it appears in the text of the paper. A reference list entry, on the other hand, details the complete information of the source being cited and is listed at the end of the paper after the main text. An example of an in-text citation and the corresponding reference list entry for a journal article with one author is listed below for your understanding:
In-text citation template and example:
Only the author name and the publication year are used in in-text citations to direct the reader to the corresponding reference list entry.
Author Surname (Publication Year)
Elden (2003)
Parenthetical
(Author Surname, Publication Year)
(Elden, 2003)
Reference list entry template and example:
Complete information of the reference is used to guide the reader to locate the source for further reference. In the below template, “F” and “M” are first and middle initials, respectively. #–# denotes the page range.
Surname, F. M. (Publication Year). Title of the article: Subtitle. Journal Title, Volume (Issue), #–#. DOI
Elden, S. (2003). Plague, panopticon, police. Surveillance & Society, 1 (3), 240–253. https://doi:10.24908/ss.v1i3.3339
When you use APA style, all sources need to have in-text citations. In-text citations direct a reader to the reference entry to get more information on the source being cited in the text. If an in-text citation is not provided, your reader doesn’t know whether there is a source available in the reference list for the idea or topic being discussed in the text. Even if all the basic elements to cite a source are not available, try to provide an in-text citation with the information you do have. For example, if a source does not have an author, use a shortened version of the title in place of the author in your in-text citation. An example is given below for a parenthetical citation.
Author name available:
(Author Surname, Publication Year, p.# for direct quote)
Author name not available:
(“Title of the Work,” Publication Year, p.# for direct quote)
Therefore, in-text citations are essential to guide a reader to locate the corresponding sources in the reference list for the topics discussed in the text.
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In-text citations are short versions of citations that give a brief indication of the sources used in the paper. They are written in the text and inform the reader that full details are available in the reference list. The information available in the list will help the reader to find and use the sources listed. To write in-text citations, you should know two important components:
Author or organization’s name
Publication date
APA uses the author-date system for in-text citations. This means that in-text citations usually include information on the author, then the date published. For example, if Harold King wrote a book in 2021, his in-text citations would look like this:
(King, 2021)
King (2021)
There are two kinds of in-text citations are available in APA style: narrative citations and parenthetical citations. Let’s review them both.
A narrative citation includes the name of the author or the organization as part of sentence text and includes the year published in parentheses. Here are two examples:
Blanchard (2020) argues that the development of a country depends on the growth of the village in the country.
API (2007) revised the guidelines for oil and natural gas field.
A parenthetical citation includes both the name of the author or the organization and the date of publication inside parentheses. A comma comes between the author and the publication date.
For quotes, parenthetical citations must also include a page number. Use “p.” for a single page and “pp.” for a page range. Here are examples:
With the author
It is argued that the development of a country depends on the growth of the village in the country (Blanchard, 2020).
It is argued that the development of a country depends on the growth of the village in the country (Blanchard, 2020, p. 17).
Organization treated as the author
It was concluded to release the revised guidelines for the oil and natural gas field (AIP, 2007).
Narrative: Author Surname (Publication date)
Parenthetical: (Author Surname, Publication date)
Narrative: Coleman (2011)
Parenthetical: (Coleman, 2011)
In narrative citations, the word “and” separates the surnames of the two authors. In parenthetical citations, use an ampersand between the two authors.
Narrative: First author Surname and Second author Surname (Publication date)
Parenthetical: (First author Surname & Second author Surname, Publication date)
Narrative: Francis and RIchter (2007)
Parenthetical: (Francis & RIchter, 2007)
If the number of authors is more than two, use “et al.” in both narrative and parenthetical citations.
Narrative: First author Surname et al. (Publication date)
Parenthetical: (First author Surname et al., Publication date)
Narrative: Rolph et al. (2017)
Parenthetical: (Rolph et al., 2017)
If a source is by a group author, use the group author name in the author’s name field. Abbreviations are allowed in a group author name. If the group name first occurs in citations, you can still abbreviate it in citations. Note that a narrative citation and a parenthetical citation have different formats in using the abbreviation when included.
If the first occurrence of an abbreviation comes in a narrative citation, include the abbreviation inside the parenthesis before the date. If your abbreviation comes first in a parenthetical citation, add the abbreviation in square brackets after the group author name as shown below:
Narrative: Group author (Abbreviation, Publication date)
Parenthetical: (Group author [Abbreviation], Publication date)
Narrative: Indian Association of Clinical Psychologists (IACP, 2008)
Parenthetical: (Indian Association of Clinical Psychologists [IACP], 2018)
For a reference with no author, you need to include the title of the paper for the in-text citations. Usually, they appear as parenthetical citations. The title is written in the same way as it is mentioned in the reference list. For example, if the title is written in italics in the list, you need to italicize it in the in-text citation as well. However, if the title is plain in the list, write using title case, meaning that you must capitalize significant words of the title and enclose it in double quotes.
Parenthetical: (“Title of the Work,” Publication date)
Parenthetical: (“Human Behavior,” 2018)
If the author of a work is given as “Anonymous,” use “Anonymous” in place of the author.
Parenthetical: (Anonymous, 2007)
Multiple citations in one sentence.
Multiple citations appearing together are arranged alphabetically within the group. Note that alphabetical arrangement is applicable only for in-text citations. The citations are separated by semicolons. Example:
(Anna, 2021; Blume & Alex, 2012; Robert, 2004)
If you include many references contributed by the same group of authors, arrange them chronologically and separate them by commas. The order of chronological citation for the same author group is (1) n.d., (2) citation with a publication date, and (3) in press. “n.d.” refers to “no date.”
(Allen, 2016a, 2016b; Bennet & Bennet, 2012, in press; Peterson, n.d., 2002)
You may have to include initials within in-text citations if multiple entries in the reference list have the same surname of the first author and same publication date, but different initials. This will aid the reader to find out the correct source of the citation. A few examples are listed below for your understanding. “F” and “M” are the first initials of the authors.
Narrative: F. Author Surname (Publication date)
Narrative: M. Author Surname (Publication date)
Parenthetical: (F. Author Surname, Publication date)
Parenthetical: (M. Author Surname, Publication date)
Narrative: G. Beauchamp (2013)
Narrative: L. Beauchamp (2013)
Parenthetical: (G. Beauchamp, 2013)
Parenthetical: (L. Beauchamp, 2013)
You may have to include a lowercase letter after the date if you have multiple entries in the reference list with the same surname of the first author, same publication date, and same initials. This will help the reader locate the correct source of a citation. This will help the reader to identify the correct source of the citation. A few examples are listed below for your understanding.
Narrative: Author Surname (Publication date followed by a suffix)
Narrative: Author Surname (Publication date followed by a different suffix)
Parenthetical: (Author Surname, Publication date followed by a suffix)
Parenthetical: (Author Surname, Publication date followed by a different suffix)
Narrative: Ikehara (2011a)
Narrative: Ikehara (2011b)
Parenthetical: (Ikehara, 2011a)
Parenthetical: (Ikehara, 2011b)
Two dates are used for a translated work: publication date of the original work and the publication date of the translated work. Both dates are added to the in-text citations. Add the publication date of the original work first followed by the date of the translated work. Use a slash as a separator between the dates.
Narrative: Author Surname (Original work’s date/Translated work’s date)
Parenthetical: (Author Surname, Original work’s date/Translated work’s date)
Narrative: Hopkins (1997/1999)
Parenthetical: (Hopkins, 1997/1999)
Works such as telephonic conversation, chat messages, personal interviews, text messages, and emails do not need any source. These are classified under personal communication. It is not possible to get the information again; therefore, they are not included in the reference list. When you want to cite personal communication, use the initials of the authors in the text. Give the exact date of personal communication.
Narrative: Communicator’s name (personal communication, Month Day, Year)
Parenthetical: (Communicator’s name, personal communication, Month Day, Year)
Narrative: T. Kirubakaran (personal communication, May 15, 2005)
Parenthetical: (T. Kirubakaran, personal communication, May 15, 2005)
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Mla quick citation guide.
Include an in-text citation when you refer to, summarize, paraphrase, or quote from another source. For every in-text citation in your paper, there must be a corresponding entry in your reference list.
MLA in-text citation style uses the author's last name and the page number from which the quotation or paraphrase is taken, for example: (Smith 163). If the source does not use page numbers, do not include a number in the parenthetical citation: (Smith).
For more information on in-text citation, see the MLA Style Center .
Example paragraph with in-text citation
A few researchers in the linguistics field have developed training programs designed to improve native speakers' ability to understand accented speech (Derwing et al. 246; Thomas 15). Their training techniques are based on the research described above indicating that comprehension improves with exposure to non-native speech. Derwing and others conducted their training with students preparing to be social workers, but note that other professionals who work with non-native speakers could benefit from a similar program (258).
Works Cited List
Derwing, Tracey M., et al. "Teaching Native Speakers to Listen to Foreign-accented Speech." Journal of Multilingual and Multicultural Development, vol. 23, no. 4, 2002, pp. 245-259.
Thomas, Holly K. Training Strategies for Improving Listeners' Comprehension of Foreign-accented Speech. University of Colorado, Boulder, 2004.
Cite web pages in text as you would any other source, using the author if known. If the author is not known, use the title as the in-text citation.
Your in-text citation should lead your reader to the corresponding entry in the reference list. Below are examples of using in-text citation with web pages.
Entire website with author: In-text citation Parents play an important role in helping children learn techniques for coping with bullying (Kraizer).
Works cited entry Kraizer, Sherryll. Safe Child. Coalition for Children, 2011, www.safechild.org.
Web page with no author: In-text citation The term Nittany Lion was coined by Penn State football player Joe Mason in 1904 ("All Things Nittany").
Works cited entry "All Things Nittany." About Penn State. Penn State University, 2006, www.psu.edu/ur/about/nittanymascot.html.
In MLA style the author's name can be included either in the narrative text of your paper, or in parentheses following the reference to the source.
Author's name part of narrative:
Gass and Varonis found that the most important element in comprehending non-native speech is familiarity with the topic (163).
Author's name in parentheses:
One study found that the most important element in comprehending non-native speech is familiarity with the topic (Gass and Varonis 163).
Group as author: (American Psychological Association 123)
Multiple works: (separate each work with semi-colons)
Research shows that listening to a particular accent improves comprehension of accented speech in general (Gass and Varonis 143; Thomas 24).
Direct quote:
One study found that “the listener's familiarity with the topic of discourse greatly facilitates the interpretation of the entire message” (Gass and Varonis 85).
Gass and Varonis found that “the listener’s familiarity with the topic of discourse greatly facilitates the interpretation of the entire message” (85).
Note: For quotations that are more than four lines of prose or three lines of verse, display quotations as an indented block of text (one inch from left margin) and omit quotation marks. Place your parenthetical citation at the end of the block of text, after the final punctuation mark.
In addition to awareness-raising, practicing listening to accented speech has been shown to improve listening comprehension. This article recommends developing listening training programs for library faculty and staff, based on research from the linguistics and language teaching fields. Even brief exposure to accented speech can help listeners improve their comprehension, thereby improving the level of service to international patrons. (O'Malley 19)
When citing works by multiple authors, always spell out the word "and." When a source has three or more authors, only the first one shown in the source is normally given followed by et al.
One author: (Field 399)
Works Cited entry: Field, John. "Intelligibility and the Listener: The Role of Lexical Stress." TESOL Quarterly , vol. 39, no. 3, 2005, pp. 399-423.
Two authors: (Gass and Varonis 67)
Works Cited entry: Gass, Susan, and Evangeline M. Varonis. "The Effect of Familiarity on the Comprehensibility of Nonnative Speech." Language Learning , vol. 34, no. 1, 1984, pp. 65-89.
Three or more authors: (Munro et al. 70)
Works Cited entry: Munro, Murray J., et al. "Salient Accents, Covert Attitudes: Consciousness-raising for Pre-service Second Language Teachers." Prospect , vol. 21, no. 1, 2006, pp. 67-79.
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Though the APA's author-date system for citations is fairly straightforward, author categories can vary significantly from the standard "one author, one source" configuration. There are also additional rules for citing authors of indirect sources, electronic sources, and sources without page numbers.
The APA manual recommends the use of the author-date citation structure for in-text citation references. This structure requires that any in-text citation (i.e., within the body of the text) be accompanied by a corresponding reference list entry. In the in-text citation provide the surname of the author but do not include suffixes such as "Jr.".
A work by two authors.
Name both authors in the signal phrase or in parentheses each time you cite the work. Use the word "and" between the authors' names within the text and use the ampersand in parentheses.
List only the first author’s name followed by “et al.” in every citation, even the first, unless doing so would create ambiguity between different sources.
In et al. , et should not be followed by a period. Only "al" should be followed by a period.
If you’re citing multiple works with similar groups of authors, and the shortened “et al” citation form of each source would be the same, you’ll need to avoid ambiguity by writing out more names. If you cited works with these authors:
They would be cited in-text as follows to avoid ambiguity:
Since et al. is plural, it should always be a substitute for more than one name. In the case that et al. would stand in for just one author, write the author’s name instead.
If the work does not have an author, cite the source by its title in the signal phrase or use the first word or two in the parentheses. Titles of books and reports are italicized; titles of articles, chapters, and web pages are in quotation marks. APA style calls for capitalizing important words in titles when they are written in the text (but not when they are written in reference lists).
Note : In the rare case that "Anonymous" is used for the author, treat it as the author's name (Anonymous, 2001). In the reference list, use the name Anonymous as the author.
If the author is an organization or a government agency, mention the organization in the signal phrase or in the parenthetical citation the first time you cite the source, just as you would an individual person.
If the organization has a well-known abbreviation, you may include the abbreviation in brackets the first time the source is cited and then use only the abbreviation in later citations. However, if you cite work from multiple organizations whose abbreviations are the same, do not use abbreviations (to avoid ambiguity).
When your parenthetical citation includes two or more works, order them the same way they appear in the reference list (viz., alphabetically), separated by a semi-colon.
If you cite multiple works by the same author in the same parenthetical citation, give the author’s name only once and follow with dates. No date citations go first, then years, then in-press citations.
To prevent confusion, use first initials with the last names.
If you have two sources by the same author in the same year, use lower-case letters (a, b, c) with the year to order the entries in the reference list. Use the lower-case letters with the year in the in-text citation.
When citing an Introduction, Preface, Foreword, or Afterword in-text, cite the appropriate author and year as usual.
For interviews, letters, e-mails, and other person-to-person communication, cite the communicator's name, the fact that it was personal communication, and the date of the communication. Do not include personal communication in the reference list.
If using a footnote to reference personal communication, handle citations the same way.
When citing information you learned from a conversation with an Indigenous person who was not your research participant, use a variation of the personal communication citation above. Include the person’s full name, nation or Indigenous group, location, and any other relevant details before the “personal communication, date” part of the citation.
Generally, writers should endeavor to read primary sources (original sources) and cite those rather than secondary sources (works that report on original sources). Sometimes, however, this is impossible. If you use a source that was cited in another source, name the original source in your signal phrase. List the secondary source in your reference list and include the secondary source in the parentheses. If you know the year of the original source, include it in the citation.
If possible, cite an electronic document the same as any other document by using the author-date style.
If no author or date is given, use the title in your signal phrase or the first word or two of the title in the parentheses and use the abbreviation "n.d." (for "no date").
When an electronic source lacks page numbers, you should try to include information that will help readers find the passage being cited. Use the heading or section name, an abbreviated heading or section name, a paragraph number (para. 1), or a combination of these.
Note: Never use the page numbers of webpages you print out; different computers print webpages with different pagination. Do not use Kindle location numbers; instead, use the page number (available in many Kindle books) or the method above.
The APA Publication Manual describes how to cite many different kinds of authors and content creators. However, you may occasionally encounter a source or author category that the manual does not describe, making the best way to proceed unclear.
In these cases, it's typically acceptable to apply the general principles of APA citation to the new kind of source in a way that's consistent and sensible. A good way to do this is to simply use the standard APA directions for a type of source that resembles the source you want to cite. For example, a sensible way to cite a virtual reality program would be to mimic the APA's guidelines for computer software.
You may also want to investigate whether a third-party organization has provided directions for how to cite this kind of source.
A publication of the harvard college writing program.
Harvard Guide to Using Sources
Colleges and universities need to create policies that foster inclusion for low-income students (Jack 24).
As Anthony Jack argues, colleges and universities need to create policies that foster inclusion for low-income students (24).
Colleges and universities need to create policies that foster inclusion for low-income students (Jack).
As Anthony Jack argues, colleges and universities need to create policies that foster inclusion for low-income students.
In The Privileged Poor, Anthony Jack describes many obstacles that low-income students face at selective colleges and universities.
Harvard College promises “to educate the citizens and citizen-leaders for our society” (“Mission, Vision, & History”).
The researchers tested whether an intervention during the first year of college could improve student well-being (Walton and Cohen 1448).
The researchers studied more than 12,000 students who were interested in STEM fields (LaCosse et al. 8).
Colleges and universities need to create policies that foster inclusion for low-income students (Jack, Privileged Poor 24).
According to Anthony Jack, colleges and universities need to create policies that foster inclusion for low-income students ( Privileged Poor 24).
As Anthony Jack writes in Privileged Poor, colleges and universities need to create policies that foster inclusion for low-income students (24).
Students who possess cultural capital, measured by proxies like involvement in literature, art, and classical music, tend to perform better in school (Bourdieu and Passeron; Dumais; Orr).
We learn that when he went to the store to buy clothes for his son, “a frantic inspection of the boys’ department revealed no suits to fit the new-born Button” (Fitzgerald, ch.2).
Guildenstern tells Hamlet that “there has been much throwing about of brains” (Shakespeare, 2.2. 381-382).
Chris is in this mindset when he says, “a couple minutes, and your whole life changes, that’s it. It’s gone” (Nottage, 13; act 1, scene1).
In the Stranger Things official trailer, the audience knows that something unusual is going to happen from the moment the boys get on their bicycles to ride off into the night (0:16).
About in-text citation, quoting and paraphrasing: what's the difference, in-text citation for two or more authors/editors, faq: how do i cite more than one source in one in-text citation, faq - how do i cite two or more works by the same author with the same year of publication, faq - how do i cite a work quoted in another source.
This guide is used/adapted with the permission of Seneca College Libraries. For information please contact [email protected] .
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In APA, in-text citations are inserted in the body of your research paper to briefly document the source of your information. Brief in-text citations point the reader to more complete information in the reference list at the end of the paper.
Signal Phrase
If you refer to the author's name in a sentence you do not have to include the name again as part of your in-text citation. Instead include the date after the name and the page number (if there is one) at the end of the quotation or paraphrased section. For example:
Hunt (2011) explains that mother-infant attachment has been a leading topic of developmental research since John Bowlby found that "children raised in institutions were deficient in emotional and personality development" (p. 358).
There are two ways to integrate others' research into your assignment: you can paraphrase or you can quote.
Paraphrasing is used to show that you understand what the author wrote. You must reword the passage, expressing the ideas in your own words, and not just change a few words here and there. Make sure to also include an in-text citation.
Quoting is copying a selection from someone else's work, phrasing it exactly it was originally written. When quoting place quotation marks (" ") around the selected passage to show where the quote begins and where it ends. Make sure to include an in-text citation.
Number of Authors/Editors | First Time Paraphrased | Second and Subsequent Times Paraphrased | First Time Quoting | Second and Subsequent Times Quoting |
---|---|---|---|---|
Two | (Case & Daristotle, 2011) | (Case & Daristotle, 2011) | (Case & Daristotle, 2011, p. 57) | (Case & Daristotle, 2011, p. 57) |
Three or more | (Case et al., 2011) | (Case et al., 2011) | (Case et al., 2011, p. 57) | (Case et al., 2011, p. 57) |
I f you would like to cite more than one source within the same in-text citation, simply record the in-text citations as normal and separate them with a semi-colon. List the sources alphabetically by author's last name or first word used from the title if no author is given, in the same order they would appear on the References List.
(Bennett, 2015; Smith, 2014).
( Brock, 2016; "It Takes Two," 2015).
When you are citing two different sources that share the same author and year of publication, assign lowercase letters after the year of publication (a, b, c, etc.). Assign these letters according to which title comes first alphabetically. Use these letters in both in-text citations and the Reference list.
Example In-Text :
Paraphrasing content from first source by this author (Daristotle, 2015a). "Now I am quoting from the second source by the same author" (Daristotle, 2015b, p. 50).
Example Reference List entries:
Daristotle, J. (2015a). Name of book used as first source . Toronto, ON: Fancy Publisher.
Daristotle, J. (2015b). Title of book used as second source . Toronto, ON: Very Fancy Publisher.
Sometimes an author of a book, article or website will mention another person’s work by using a quotation or paraphrased idea from that source. The work that is mentioned in the article you are reading is called the primary source. The article you are reading is called the secondary source.
For example, suppose you are reading an article by Brown (2014) that cites information from an article by Snow (1982) that you would like to include in your essay. For the reference list, you will only make a citation for the secondary source (Brown). You do not put in a citation for the primary source (Snow) in the reference list. For the in-text citation, you identify the primary source (Snow) and then write "as cited in" the secondary source (Brown). If you know the year of the publication of the primary source, include it in the in-text citation. Otherwise, you can omit it. See below for examples.
Examples of in-text citations:
According to a study by Snow (1982, as cited in Brown, 2014), 75% of students believe that teachers should not assign nightly homework.
Note: If you don't have the publication date of Snow's article, you just omit it like this: According to a study by Snow (as cited in Brown, 2014), 75% of students believe that teachers should not assign nightly homework.
In fact, 75% of students believe that teachers should not assign nightly homework (Snow, 1982, as cited in Brown, 2014).
Snow (1982, as cited in Brown, 2014) concluded that "nightly homework is a great stressor for many students" (p.34).
Example of Reference list citation:
Brown, S. (2014). Trends in homework assignments. Journal of Secondary Studies , 12(3) , 29-38. http://doi.org/fsfsbit
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There are many different ways to cite a website, depending on which citation style you need to format it in.
Use our citation generator below to automatically cite a website in any style, including APA, MLA 7 and 8, and Harvard. Just select the style you need, copy the URL into the search box, and press search. We’ll do the rest.
To cite a website by hand just follow the instructions below. For the 3 most popular styles–APA, MLA 8, and Harvard–this is as follows:
You need to locate these details for the website: page or article author, page or article title, website name, published date, access date, page URL (web address) .
Then use this template, replacing the colored placeholders with the information you found on the page:
Author last name , author first name initial . ( published year , published month and day ). Page title . Retrieved accessed month and day , accessed year , from article URL .
The final formatted citation should look like this:
Ingle, S. (2018, February 11). Winter Olympics was hit by cyber-attack, officials confirm. Retrieved July 24, 2018, from https://www.theguardian.com/sport/2018/feb/11/winter-olympics-was-hit-by-cyber-attack-officials-confirm.
For a more comprehensive guide, including what to do when you can’t find certain details, have a look at our more in-depth guide to citing a website in APA format .
Here are the specific details you need to find on the page: page or article author, page or article title, website name, published date, access date, page URL (web address) .
Then use this template:
Author last name , author first name . “ Page title .” website name , published date day, month, year , page URL . Accessed accessed date day, month, year .
Ingle, Sean. “Winter Olympics Was Hit by Cyber-Attack, Officials Confirm.” The Guardian , 11 Feb. 2018, https://www.theguardian.com/sport/2018/feb/11/winter-olympics-was-hit-by-cyber-attack-officials-confirm. Accessed 13 July 2018.
For a more comprehensive guide, including what to do when you can’t find certain details, have a look at our more in-depth guide to citing a website in MLA 8 format .
First, find these details for the website: page or article author, page or article title, website name, published date, access date, page URL (web address) .
Author last name , author firstname initial ( published date year ). Page title . [online] website name . Available at: page URL [Accessed accessed date day, month, year ].
Ingle, S. (2018). Winter Olympics was hit by cyber-attack, officials confirm . [online] The Guardian. Available at: https://www.theguardian.com/sport/2018/feb/11/winter-olympics-was-hit-by-cyber-attack-officials-confirm [Accessed 13 Jul. 2018].
Daniel is a qualified librarian, former teacher, and citation expert. He has been contributing to MyBib since 2018.
When citing multiple works parenthetically, place the citations in alphabetical order, separating them with semicolons.
(Adams et al., 2019; Shumway & Shulman, 2015; Westinghouse, 2017)
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As Senator JD Vance seeks the vice presidency, a former Yale Law School classmate and friend has shared about 90 of their emails and text messages, mostly from 2014 through 2017, with The New York Times.
The emails add to an existing body of evidence showing how Mr. Vance pivoted from a strong opponent of former President Donald J. Trump to his running mate. They also provide an insight into a cultural willingness by Mr. Vance to accept his classmate, Sofia Nelson, who is transgender.
Nelson, now a public defender in Detroit, said the two were once close friends, but had a falling out in 2021, when Mr. Vance said publicly that he supported an Arkansas ban on gender-affirming care for minors. Now, Nelson, who opposes the Trump-Vance ticket, hopes the emails will inform the opinion of voters about Mr. Vance.
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Oct. 23, 2014
In October 2014, in the wake of the killing of Michael Brown, a Black 18-year-old, by a white police officer in Ferguson, Mo., Nelson raised the idea of requiring that police officers wear body cameras.
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Full source title or organization name | In-text citation |
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You must include an MLA in-text citation every time you quote or paraphrase from a source (e.g. a book , movie , website , or article ).
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Introduction, materials and methods, data availability, acknowledgements, authors’ roles, conflict of interest.
Xiuxian Zhu and Jingwen Lang authors contributed equally to this work.
Xiuxian Zhu, Jingwen Lang, Qiaoling Wang, Yonglun Fu, Extended versus conventional letrozole regimen in patients with polycystic ovary syndrome undergoing their first ovulation induction cycle: a prospective randomized controlled trial, Human Reproduction Open , Volume 2024, Issue 3, 2024, hoae046, https://doi.org/10.1093/hropen/hoae046
Can an extended letrozole (LE) regimen result in a higher ovulatory rate than a conventional regimen in patients with polycystic ovary syndrome (PCOS) undergoing their first ovulation induction cycle?
There was no statistical difference in ovulation rate between patients with PCOS using the extended LE regimen and those using the conventional LE regimen.
LE has become the first-line agent for ovulation induction. However, there is still a proportion of non-responsive cycles in patients with PCOS undergoing ovulation induction therapy with LE alone, and the extended LE regimen has been demonstrated to be a feasible method for inducing ovulation in these non-responders. Nevertheless, whether the extended regimen could be applied to all patients with PCOS as a first choice for the induction of ovulation remains to be explored.
This was a prospective randomized controlled trial that included 148 female patients with PCOS who underwent their first ovulation induction cycle with LE from January 2021 to October 2022.
Participants were randomly assigned to receive an extended (5 mg LE daily for 7 days) or conventional regimen (5 mg LE daily for 5 days) for one treatment cycle. The ovulation rate was the primary outcome. Secondary outcomes included the clinical pregnancy rate, the number of preovulatory follicles, and the rate of multiple pregnancies.
The ovulation rate among patients receiving an extended LE regimen was slightly higher than the rate with a conventional LE regimen, but the difference did not reach statistical significance in either the intention-to-treat analysis (90.54% [67/74] vs 79.73% [59/74], P = 0.065; relative risk [95% CI]: 0.881 [0.768–1.009]) or the per-protocol analysis (90.54% [67/74] vs 84.29% [59/70], P = 0.257; relative risk [95% CI]: 0.931 [0.821–1.055]). The number of preovulatory follicles was nearly identical in the two groups (1.39 ± 0.62 vs 1.37 ± 0.59, P = 0.956), and no cases of ovarian hyperstimulation syndrome were observed. With regards to the endometrial parameters, the mean endometrium thickness was slightly thicker with the conventional LE regimen compared to that with the extended LE regimen, though with no statistical difference (9.27 ± 1.72 mm vs 9.57 ± 2.28 mm, P = 0.792). In the per-protocol analysis, the rates of clinical pregnancy (20.27% [15/74] vs 14.29% [10/70], P = 0.343; relative risk [95% CI]: 0.705 [0.34–1.463]) and live birth (13.51% [10/74] vs 11.43% [8/70], P = 0.705; relative risk [95% CI]: 0.846 [0.354–2.019]) did not differ significantly between treatment groups. Moreover, all conceptions were singletons without neonatal defects.
The major concerns regarding this study are its single-center and open-label nature. Additionally, the limited number of lean patients with PCOS with a mean body mass index of 23–25 kg/m 2 enrolled in our trial also restricted the generalizability of our findings.
A change from the standard strategy of ovulation induction in patients with PCOS is not advisable, because a statistically superior effect of the extended LE regimen over a conventional regimen was not detected. The extended LE regimen could be applied with caution in a specific population who failed to respond to a conventional regimen rather than all the patients with PCOS during ovulation induction. Additional prospective trials with larger sample sizes and different PCOS subgroups are needed to assess the ovulatory effects of various LE treatment durations.
This study was funded by the Shanghai First Maternity and Infant Hospital, affiliated with Tongji University School of Medicine (grant numbers: 2023B03 to Y.F., 2023B18 to X.Z., and 2020RC02 to Y.F.). The authors report no conflicts of interest.
Chinese Clinical Trial Registry (ChiCTR2100042082).
13 January 2021.
21 January 2021.
Letrozole has become the most commonly prescribed oral ovulation induction agent for subfertile women who do not ovulate naturally, particularly those with polycystic ovary syndrome (PCOS). However, there is still a proportion of patients with PCOS who fail to respond to conventional letrozole therapy. The extended letrozole regimen has been demonstrated to be a feasible method for inducing ovulation in these ‘non-responders’. Nevertheless, whether this may be applied to all patients with PCOS as the first choice for the induction of ovulation remains to be explored. Thus, we conducted this prospective randomized controlled study to assess whether an extended letrozole regimen is superior to the conventional letrozole regimen in patients with PCOS when undergoing their first ovulation induction cycle. Our data showed that the rate of ovulation among patients receiving an extended letrozole regimen was slightly higher than the rate with a conventional letrozole regimen group, but the difference did not reach statistical significance. In consideration of the potential risk of multi-follicular development with the extended letrozole regimen, which would require more monitoring and higher costs to avoid multiple pregnancies, we conclude that it is not necessary to replace the conventional regimen with an extended letrozole regimen in patients with PCOS during their first ovulation induction cycle.
Ovulatory dysfunction is a major cause of infertility in patients with polycystic ovary syndrome (PCOS) ( Balen et al. , 2016 ; Teede et al. , 2023 ), and letrozole (LE) has become the most commonly prescribed oral ovulation induction agent ( Wang et al. , 2019 ; Pundir et al. , 2021 ; Tsiami et al. , 2021 ; Franik et al. , 2022 ; Liu et al. , 2023 ). However, there is still a proportion of non-responsive cycles in patients with PCOS undergoing ovulation induction therapy with LE alone ( Ramezanzadeh et al. , 2011 ; Legro et al. , 2014 ; Wu et al. , 2016 ; Amer et al. , 2017 ; Mejia et al. , 2019 ; Shi et al. , 2022 ; Dai et al. , 2023 ; Sharma et al. , 2023 ). Exogenous gonadotropin is the most commonly used drug for these non-responders with an increased risk of multiple-follicular development, subsequent cycle cancellation, severe ovarian hyperstimulation syndrome (OHSS), or multiple pregnancies ( Weiss et al. , 2019 ; Chen et al. , 2023 ; Dai et al. , 2023 ; Xia et al. , 2023 ). Therefore, it is urgent to explore other options for inducing ovulation in those non-responsive patients.
Our team first proposed the method of extending the LE treatment duration step by step to induce follicle growth in patients with PCOS who could not achieve ovulation with the conventional 5-day LE regimen ( Zhu and Fu, 2023 ), referred to as ‘LE resistance’ ( Guo et al. , 2023 ; Neblett et al. , 2023 ). Our data showed that 48 out of 69 patients with LE resistance (69.57%) achieved ovulation with 7 days of treatment of LE 5 mg per day, and a further 16 patients (23.19%) ovulated after receiving another 10 days of treatment ( Zhu and Fu, 2023 ). Since the ovulatory effect of the extended LE regimen was compelling, it was worth asking whether it could be applied to all patients with PCOS as a first choice for inducing ovulation. Thus, we designed this prospective randomized controlled study to assess whether an extended LE regimen is superior to the conventional LE regimen in patients with PCOS undergoing their first ovulation induction cycle.
The study protocol was approved by the hospital’s Institutional Review Board. The trial was registered with the Chinese Clinical Trial Registry (ChiCTR2100042082). Written informed consent was obtained from every participant before randomization.
This prospective randomized controlled study was conducted at the Shanghai First Maternity and Infant Hospital from January 2021 to October 2022.
Outpatients with PCOS who underwent their first ovulation induction cycle were screened. The inclusion criteria were as follows: (i) a diagnosis of PCOS based on a modified form of the Rotterdam criteria ( Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group, 2004 ): chronic anovulation or oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and polycystic ovaries on ultrasonography; (ii) aged 20–35 years; and (iii) normal semen analysis of their male partners.
Patients with a previous history of ovulation induction failures or other diseases such as active thyroid disease, congenital adrenal hyperplasia, hyperprolactinemia, androgen-secreting tumors, Cushing’s syndrome, and clinically significant systemic diseases were excluded. In addition, those who had received drugs that interfered with hormone levels in the previous three months were not enrolled in our study.
Participants were randomly assigned to receive an extended or conventional LE regimen for one treatment cycle. Specifically, LE 5 mg (Letrozole tablets; Yimeishu ® , Zhejiang Hisun Pharmaceutical Co., Ltd, Taizhou, China) was prescribed orally daily for seven consecutive days in the study group and for five consecutive days in the control group, starting on days 2–4 of the menstrual period or progesterone (P)-induced bleeding. To observe the ovarian response in as much detail as possible, an ultrasound was performed every 2–4 days after the last dose of LE to record the number/size of follicles and endometrial thickness; meanwhile, serum hormone levels were determined with a chemiluminescent method (Abbott Biologicals B.V., Weesp, The Netherlands). The lower limits of sensitivity were as follows: FSH 0.06 IU/l, luteinizing hormone (LH) 0.09 IU/l, estradiol (E 2 ) 10 pg/ml, and P 0.1 ng/ml. The E 2 values were recorded as 5000 pg/ml if it surpassed 5000 pg/ml.
Ovulation was diagnosed by the disappearance of a follicle greater than 14 mm or a serum P level >3 ng/ml followed by pregnancy or menses. If no follicles with a diameter >10 mm were detected, concomitant with E 2 <70 pg/ml and P < 1.0 ng/ml 14 days after the last dose of LE, dydrogesterone (Duphaston; Abbott Biologicals B.V.) was delivered to induce bleeding.
Couples were advised to engage in regular intercourse every 2–4 days and timed intercourse if an LH surge was detected. Serum hCG levels were tested 2 weeks after ovulation to diagnose conception and an ultrasound was performed 4 weeks to diagnose a clinical pregnancy. Pregnancy and neonatal outcomes were tracked through a review of maternal and infant medical records. A nurse supervised and checked whether participants had complied well with their prescriptions by asking and checking the surplus LE tablets.
The primary outcome was ovulation rate; secondary outcomes included the clinical pregnancy rate, number of preovulatory follicles (with a diameter larger than 14 mm), and rate of multiple pregnancies (the presence of two or more gestational sacs in the uterine cavity). Other outcomes included the largest follicle diameter, endometrial thickness, time-to-ovulation (the number of days from the first dose of LE to ovulation), mono-follicular rate (cycles with one follicle ≥14 mm per ovulatory cycle), and rates of OHSS, biochemical pregnancy, early miscarriage (loss of pregnancy before 12 weeks of gestation), and live birth (defined as a live baby born after 28 weeks of gestation). Both ectopic pregnancies and the presence of a gestational sac in the uterus, as determined using ultrasonography, were considered clinical pregnancies.
To demonstrate a clinically meaningful difference of 20% between the previously reported ovulation rate of the conventional (∼75%) and extended LE regimen with a two-sided significance level of 0.05 and power of 85%, a sample size of 132 participants (66 per arm) was required (PASS 15.0.5). The sample size was increased to 74 participants per arm to allow for ∼10% dropouts.
The enrolled participants were allocated in a ratio of 1:1 to receive treatment with either the extended or the conventional LE regimen according to a randomization list generated by the trial statistician using Statistical Analysis System (SAS) 9.4. The enrolment order and the treatment code (A or B) were sealed in an opaque envelope with random numbers. Participants and physicians were not blinded to the group assignment. However, the sonographers were blinded to the group assignments in the trial.
The intention-to-treat (ITT) analysis included all randomized participants regardless of whether they were lost to follow-up, whereas the per-protocol (PP) analysis included those who completed the allocated treatment and follow-up. Participants who were lost to follow-up were assumed neither to ovulate nor be pregnant in the ITT analysis.
Categorical variables were assessed using the chi-squared test or Fisher’s exact test. Student’s t -test was used to assess continuous variables in each normally or near-normally distributed group, and the Mann–Whitney U test was used to assess continuous variables with a non-normal distribution. Statistical analyses were performed using SPSS 20 for Windows (release 6.0; IBM Corporation, Armonk, NY, USA). All P -values were two-sided, and a P -value of <0.05 was considered statistically significant.
Figure 1 presents a flowchart of the trial. A total of 197 patients with PCOS were screened and 148 were enrolled in this study. Four patients in the conventional LE regimen group were lost to follow-up after their first visit. The remaining 144 completed the allocated treatments. As shown in Table 1 , the mean maternal age in the extended LE regimen group was higher than that in the conventional LE regimen group. However, the difference was not clinically significant. Other baseline characteristics of the two groups were similar.
Flowchart of the study. ITT, intention-to-treat; PP, per-protocol.
Baseline characteristics of participants.
Characteristic . | The extended letrozole regimen . | The conventional letrozole regimen . | -values . |
---|---|---|---|
(n = 74) . | (n = 74) . | ||
Maternal age (years) | 29.68 ± 3.44 | 28.40 ± 3.15 | 0.023 |
Infertility duration (years) | 2.1 ± 1.36 | 1.93 ± 1.27 | 0.426 |
AMH (ng/ml) | 10.21 ± 4.87 | 9.72 ± 4.32 | 0.740 |
BMI (kg/m ) | 24.04 ± 4.3 | 23.5 ± 3.6 | 0.513 |
Number of patients in each BMI group, n (%) | |||
<18.5 kg/m | 5 (6.76%) | 4 (5.41%) | 0.849 |
18.5–25 kg/m | 39 (52.7%) | 45 (60.81%) | |
25–30 kg/m | 25 (33.78%) | 21 (28.38%) | |
≥30 kg/m | 5 (6.76%) | 4 (5.41%) | |
Type of infertility, n (%) | |||
Primary infertility | 51 (68.92%) | 56 (75.68%) | 0.358 |
Secondary infertility | 23 (31.08%) | 18 (24.32%) | |
Menstrual dysfunction, n (%) | |||
Oligomenorrhea | 65 (87.84%) | 67 (90.54%) | 0.597 |
Amenorrhea | 9 (12.16%) | 7 (9.46%) | |
PCOS diagnosis, n (%) | |||
Polycystic ovaries | 74 (100%) | 74 (100%) | 0.756 |
Hyperandrogenism (clinical or laboratory) | 3 (4.05%) | 1 (1.35%) | |
Menstrual dysfunction | 74 (100%) | 74 (100%) | |
Fallopian tube patency, n (%) | |||
One patent tube | 6 (8.11%) | 5 (6.76%) | 0.648 |
Bilateral patent tube | 18 (24.32%) | 23 (31.08%) | |
No test records | 50 (67.57%) | 46 (62.16%) |
Characteristic . | The extended letrozole regimen . | The conventional letrozole regimen . | -values . |
---|---|---|---|
(n = 74) . | (n = 74) . | ||
Maternal age (years) | 29.68 ± 3.44 | 28.40 ± 3.15 | 0.023 |
Infertility duration (years) | 2.1 ± 1.36 | 1.93 ± 1.27 | 0.426 |
AMH (ng/ml) | 10.21 ± 4.87 | 9.72 ± 4.32 | 0.740 |
BMI (kg/m ) | 24.04 ± 4.3 | 23.5 ± 3.6 | 0.513 |
Number of patients in each BMI group, n (%) | |||
<18.5 kg/m | 5 (6.76%) | 4 (5.41%) | 0.849 |
18.5–25 kg/m | 39 (52.7%) | 45 (60.81%) | |
25–30 kg/m | 25 (33.78%) | 21 (28.38%) | |
≥30 kg/m | 5 (6.76%) | 4 (5.41%) | |
Type of infertility, n (%) | |||
Primary infertility | 51 (68.92%) | 56 (75.68%) | 0.358 |
Secondary infertility | 23 (31.08%) | 18 (24.32%) | |
Menstrual dysfunction, n (%) | |||
Oligomenorrhea | 65 (87.84%) | 67 (90.54%) | 0.597 |
Amenorrhea | 9 (12.16%) | 7 (9.46%) | |
PCOS diagnosis, n (%) | |||
Polycystic ovaries | 74 (100%) | 74 (100%) | 0.756 |
Hyperandrogenism (clinical or laboratory) | 3 (4.05%) | 1 (1.35%) | |
Menstrual dysfunction | 74 (100%) | 74 (100%) | |
Fallopian tube patency, n (%) | |||
One patent tube | 6 (8.11%) | 5 (6.76%) | 0.648 |
Bilateral patent tube | 18 (24.32%) | 23 (31.08%) | |
No test records | 50 (67.57%) | 46 (62.16%) |
Data are presented as n, mean ± SD or n (%).
Mann–Whitney U test (for continuous variables).
Fisher’s exact test (for categorical variables).
Pearson chi-square (for categorical variables).
AMH, anti-Müllerian hormone; BMI, body mass index; PCOS, polycystic ovary syndrome.
As shown in Table 2 , the ovulation rate among patients receiving an extended LE regimen was slightly higher than the rate with a conventional LE regimen, but the difference did not reach a statistical significance in either the ITT analysis (90.54% [67/74] vs 79.73% [59/74], P = 0.065; relative risk [95% CI]: 0.881 [0.768–1.009]) or the PP analysis (90.54% [67/74] vs 84.29% [59/70], P = 0.257; relative risk [95% CI]: 0.931 [0.821–1.055]).
Reproductive outcomes.
Measured parameters . | The extended letrozole regimen . | The conventional letrozole regimen . | . | -values . |
---|---|---|---|---|
Ovulation rate | 67/74 (90.54%) | 59/74 (79.73%) | 0.881 (0.768–1.009) | 0.065 |
Clinical pregnancy rate | 15/74 (20.27%) | 10/74 (13.51%) | 0.667 (0.321–1.387) | 0.273 |
Multiple pregnancy rate | 0/15 (0%) | 0/10 (0%) | — | — |
Live birth rate | 10/74 (13.51%) | 8/74 (10.81%) | 0.82 (0.34–1.973) | 0.656 |
Ovulation rate | 67/74 (90.54%) | 59/70 (84.29%) | 0.931 (0.821–1.055) | 0.257 |
Biochemical pregnancy rate | 17/74 (22.97 %) | 12/70 (17.14%) | 0.746 (0.385–1.448) | 0.383 |
Clinical pregnancy rate | 15/74 (20.27%) | 10/70 (14.29%) | 0.705 (0.34–1.463) | 0.343 |
Multiple pregnancy rate | 0/15 (0%) | 0/10 (0%) | — | — |
Ectopic pregnancy rate | 1/15 (6.67 %) | 0/10 (0%) | — | — |
Early miscarriage rate | 4/15 (26.67%) | 2/10 (20%) | 0.75 (0.168–3.351) | 1.000 |
Live birth rate | 10/74 (13.51%) | 8/70 (11.43%) | 0.846 (0.354–2.019) | 0.705 |
Measured parameters . | The extended letrozole regimen . | The conventional letrozole regimen . | . | -values . |
---|---|---|---|---|
Ovulation rate | 67/74 (90.54%) | 59/74 (79.73%) | 0.881 (0.768–1.009) | 0.065 |
Clinical pregnancy rate | 15/74 (20.27%) | 10/74 (13.51%) | 0.667 (0.321–1.387) | 0.273 |
Multiple pregnancy rate | 0/15 (0%) | 0/10 (0%) | — | — |
Live birth rate | 10/74 (13.51%) | 8/74 (10.81%) | 0.82 (0.34–1.973) | 0.656 |
Ovulation rate | 67/74 (90.54%) | 59/70 (84.29%) | 0.931 (0.821–1.055) | 0.257 |
Biochemical pregnancy rate | 17/74 (22.97 %) | 12/70 (17.14%) | 0.746 (0.385–1.448) | 0.383 |
Clinical pregnancy rate | 15/74 (20.27%) | 10/70 (14.29%) | 0.705 (0.34–1.463) | 0.343 |
Multiple pregnancy rate | 0/15 (0%) | 0/10 (0%) | — | — |
Ectopic pregnancy rate | 1/15 (6.67 %) | 0/10 (0%) | — | — |
Early miscarriage rate | 4/15 (26.67%) | 2/10 (20%) | 0.75 (0.168–3.351) | 1.000 |
Live birth rate | 10/74 (13.51%) | 8/70 (11.43%) | 0.846 (0.354–2.019) | 0.705 |
CI, confidence interval; RR, relative risk.
Among patients who ovulated, the mono-follicular and bifollicular rates were comparable between the two groups ( Fig. 2A , Table 3 ). One woman in the study group and three patients in the control group yielded three dominant follicles, while four preovulatory follicles were found in one of the participants receiving the extended LE regimen ( Table 3 ). No significant differences were found between groups when it came to the number of preovulatory follicles, the average largest follicle size, time-to-ovulation, or endometrial thickness ( Table 3 ). The largest follicle diameter documented before ovulation was 30.6 mm among the extended LE regimen recipients and 30.3 mm among the conventional LE regimen recipients ( Fig. 2B ). All patients ovulated spontaneously without triggers, and no cases of OHSS were reported in either group ( Table 3 ). With regards to the endometrial parameters ( Fig. 2C , Table 3 ), the mean endometrium thickness was slightly thicker with the conventional LE regimen compared to the extended LE regimen, though with no statistical difference (9.27 ± 1.72 mm vs 9.57 ± 2.28 mm, P = 0.792). In addition, only four patients in the extended LE regimen group and three in the conventional LE regimen group showed endometrial thickness <7 mm ( Fig. 2C ). Time-to-ovulation ranged from 9 to 21 days among patients who received the extended LE regimen, similar to that among patients who received the conventional LE regimen (9–22 days) ( Fig. 2D ).
Cycle characteristics. ( A ) The distribution of women in the two groups with follicle diameter >14 mm; ( B ) the largest follicle diameter; ( C ) endometrial thickness; and ( D ) the time of ovulation in ovulatory cycles. Time-to-ovulation refers to the number of days from the first dose of letrozole administration to ovulation. The blue boxes represent the women who underwent the extended letrozole regimen, and the orange boxes represent those who underwent the conventional letrozole regimen.
Cycle characteristics in ovulatory cycles.
Measured parameters . | The extended letrozole regimen . | The conventional letrozole regimen . | -values . |
---|---|---|---|
(n = 67) . | (n = 59) . | ||
Number of preovulatory follicles | 1.39 ± 0.62 | 1.37 ± 0.59 | 0.956 |
Largest follicle size (mm) | 21.35 ± 3.88 | 22.18 ± 3.72 | 0.251 |
Time-to-ovulation (days) | 13.97 ± 2.61 | 14.11 ± 2.81 | 0.84 |
Endometrial thickness (mm) | 9.27 ± 1.72 | 9.57 ± 2.28 | 0.792 |
Mono-follicular rate, % (n) | 47/67 (70.15%) | 42/59 (71.19%) | 0.898 |
Bifollicular rate, % (n) | 18/67 (26.87%) | 14/59 (23.73%) | 0.686 |
Cycles of spontaneous ovulation | 67 | 59 | — |
OHSS cases | 0 | 0 | — |
Measured parameters . | The extended letrozole regimen . | The conventional letrozole regimen . | -values . |
---|---|---|---|
(n = 67) . | (n = 59) . | ||
Number of preovulatory follicles | 1.39 ± 0.62 | 1.37 ± 0.59 | 0.956 |
Largest follicle size (mm) | 21.35 ± 3.88 | 22.18 ± 3.72 | 0.251 |
Time-to-ovulation (days) | 13.97 ± 2.61 | 14.11 ± 2.81 | 0.84 |
Endometrial thickness (mm) | 9.27 ± 1.72 | 9.57 ± 2.28 | 0.792 |
Mono-follicular rate, % (n) | 47/67 (70.15%) | 42/59 (71.19%) | 0.898 |
Bifollicular rate, % (n) | 18/67 (26.87%) | 14/59 (23.73%) | 0.686 |
Cycles of spontaneous ovulation | 67 | 59 | — |
OHSS cases | 0 | 0 | — |
OHSS, ovarian hyperstimulation syndrome.
Figure 3 depicts the dynamic hormone profiles of the ovulatory cycles in all participants. Day 1 represents the day on which LE treatment was initiated. The mean FSH levels were slightly higher in the extended LE regimen than in the conventional LE regimen group throughout the ovulation induction cycle; however, the differences were not statistically significant. No between-group differences were found in the average serum LH levels on Days 7–10 and on the pre-ovulation day. The average E 2 levels on the pre-ovulation day were higher in the conventional LE regimen group than in the extended LE regimen group, although the difference was not statistically significant. The serum P levels of the two groups were similar during treatment.
Hormone profile during treatment. Serum hormone levels during ovarian stimulation in ovulatory cycles in the two letrozole regimens. The red lines represent the extended letrozole regimen group, and the green lines represent the conventional letrozole regimen group. The day of treatment initiation was recorded as Day 1 of each regimen. * P < 0.05 at the time point. FSH, follicle-stimulating hormone; LH, luteinizing hormone; E 2 , estradiol; P, progesterone.
In the PP analysis, the rates of clinical pregnancy (20.27% [15/74] vs 14.29% [10/70], P = 0.343; relative risk [95% CI]: 0.705 [0.34–1.463]) and live birth (13.51% [10/74] vs 11.43% [8/70], P = 0.705; relative risk [95% CI]: 0.846 [0.354–2.019]) did not differ significantly between the treatment groups ( Table 2 ), and similar outcomes were noted in the ITT analysis. All pregnant patients in our study were diagnosed as having singleton pregnancies. Four miscarriages occurred in the extended LE regimen group and two miscarriages occurred in the conventional LE regimen group. One patient in each group experienced preterm delivery at 33–34 weeks with good neonatal outcomes. Additionally, no early neonatal death or congenital birth defects were detected.
This is the first prospective randomized controlled trial to illustrate the ovarian response, hormone profile, and pregnancy outcomes of patients with PCOS using an extended LE regimen compared with a conventional LE regimen. Our results showed that the rate of ovulation among patients receiving an extended LE regimen was slightly higher than the rate with a conventional LE regimen group. However, this difference did not reach statistical significance. Our findings suggest that it is not necessary to replace the conventional LE regimen with an extended LE regimen in patients with PCOS during their first ovulation induction cycle.
The major concern with regard to extending LE duration was multi-follicular growth. Fouda and Sayed (2011) first documented the use of an extended LE regimen. That study enrolled 106 normal-ovulatory patients treated with LE 2.5 mg per day from cycle days 1 to 9 and revealed a clinical pregnancy rate of 18.96% (40/211) and a multiple pregnancy rate of 4/40 (10%) in those patients ( Fouda and Sayed, 2011 ). Although no cases of OHSS were reported and all the multiple pregnancies were twins, the average number of follicles >18 mm on the day of hCG administration reached 2.24 ± 0.80 after 9 days of LE treatment ( Fouda and Sayed, 2011 ). In our trial, the LE treatment duration was prolonged to 7 instead of 10 days. Although the average number of preovulatory follicles was comparable between treatment groups, one woman using the extended LE regimen yielded four dominant follicles but failed to conceive in this cycle. The most ideal case during ovulation induction therapy would be mono-follicular development and subsequent mono-ovulation and singleton pregnancy ( Balen et al. , 2016 ; Birch Petersen et al. , 2016 ; Teede et al. , 2023 ). Although all the conceptions were singletons without neonatal anomalies in our trial, the potential risk of multi-follicular development and multiple pregnancies that would require more monitoring and result in higher costs by applying the extended LE regimen could not be ignored. Therefore, we do not advise to use the extended LE regimen for standard ovulation induction in women with PCOS. Nevertheless, it could be applied as a feasible alternative in a specific population with PCOS who fail to respond to a conventional LE regimen.
Applying an exogenous hCG to trigger ovulation is a popular practice prior to intercourse or intrauterine insemination in women with ovulatory dysfunction ( Palatnik et al. , 2012 ; Hancock et al. , 2021 ; Chen et al. , 2023 ; Dai et al. , 2023 ). However, the optimal follicular diameters to apply trigger drugs remain a controversy. Palatnik et al. observed a higher pregnancy rate when the leading follicles were triggered at a size of 23–28 mm during intrauterine insemination cycles with LE ( Palatnik et al. , 2012 ), while Hancock et al. identified hCG administration at a lead follicle size of 21.1–22.0 mm was associated with higher pregnancy rates in patients with ovulatory dysfunction or unexplained infertility during intrauterine insemination treatments ( Hancock et al. , 2021 ). From our perspective, it is preferable that dominant follicles rupture spontaneously without the application of exogenous trigger drugs. As a type of aromatase inhibitor, LE could promote FSH production and follicular growth by inhibiting estrogen biosynthesis ( Wang et al. , 2019 ; Pundir et al. , 2021 ; Tsiami et al. , 2021 ; Franik et al. , 2022 ; Liu et al. , 2023 ). Owing to the short half-life of LE (∼45 h), serum E 2 values could rapidly rise after the cessation of LE treatment, and then evoke substantial LH secretion and subsequent ovulation ( Rose and Brown, 2020 ; Yang et al. , 2021 ). All the participants with dominant follicles achieved spontaneous ovulation without exogenous trigger drugs in our trial. The strategy of waiting for the spontaneous LH surge ensured that there was sufficient time for estrogen biosynthesis and endometrial development. As a result, the mean endometrial thickness before ovulation was comparable between the treatment groups, which was in consistent with previous studies using the extended regimens (7–10 days) ( Fouda and Sayed, 2011 ; Zhu and Fu, 2023 ). In other words, a duration-dependent reduction in endometrial thickness was not observed in our trial. Furthermore, the clinical pregnancy rate and the live birth rate in patients using the extended LE regimen were similar to those in patients with the conventional LE regimen. Therefore, it is not necessary to worry about the reduced endometrial thickness during ovulation induction cycles with the extended LE regimen.
One of the main limitations is that the sample size of our trial was rather small. In addition, one should be cautious when interpreting our findings as the patients enrolled in the present study were lean patients with PCOS with a mean BMI of 23–25 kg/m 2 , and the incidence of patients with LE resistance (∼15%) was less than that reported in most prior articles ( Ramezanzadeh et al. , 2011 ; Legro et al. , 2014 ; Wu et al. , 2016 ; Amer et al. , 2017 ; Mejia et al. , 2019 ; Shi et al. , 2022 ; Dai et al. , 2023 ; Sharma et al. , 2023 ), limiting the applicability of our results in obese patients. Nevertheless, we believe that our cohort was a good representation of the Chinese PCOS community as the mean BMI was 22.2 ± 4.2 kg/m 2 and the prevalence of patients with a BMI≥23 kg/m 2 was 34.09% (284/833) based on a large community study of Han Chinese patients ( Li et al. , 2013 ). Moreover, it may be argued that the definition of PCOS adopted in our trial was outdated because the threshold for polycystic ovary morphology was having more than 20 antral follicles in at least one ovary, according to the recent guidelines published in 2023. However, the Rotterdam criteria remain the most universally accepted diagnostic criteria for PCOS in practice. Besides, there were very few participants with clinical or biochemical hyperandrogenism enrolled in our trial, thus further studies with different PCOS subtypes in a larger population are needed to validate our findings. Additionally, the primary outcome in the present trial was ovulation rate. We acknowledge that the rates of clinical pregnancy or live birth would have been a more suitable parameter for comparing the ovulatory effects during ovulation induction treatments. Nevertheless, the formation of dominant follicles is the first and core step of successful ovulation induction. It may be more meaningful to evaluate the pregnancy rate and delivery rate on the premise of differences in ovulation rate. Another concern was that the treatment allocation was not blinded to the participants and investigators. The combined assessment of ultrasound and serum hormone levels ensured the objectivity and accuracy of the data relevant to ovulation, which may reduce any bias from an open-label design. Finally, cumulative ovulation rates and pregnancy outcomes were not available as only one ovulation induction cycle was incorporated into our study. Additional studies could be conducted to obtain cumulative outcomes in patients with PCOS using an extended LE regimen and provide detailed records relevant to side effects and follow-up of newborns ( Legro et al. , 2020 ).
Our data supported the use of a conventional LE regimen in patients with PCOS undergoing their first ovulation induction cycle because a statistically superior effect of the extended LE regimen over a conventional regimen was not detected. Additional prospective trials with larger sample sizes and different subgroups of PCOS are needed to assess the ovulatory effects of different LE treatment durations.
The data underlying this article will be shared on reasonable requests made to the corresponding author.
The authors thank the staff of the Department of Assisted Reproduction in Shanghai First Maternity and Infant Hospital for their cooperation and support.
Y.F. conceptualized the study. X.Z. and J.L. collected the data and performed the statistical analysis. X.Z. wrote the manuscript. Y.F. and Q.W. revised the manuscript. All authors contributed to the critical revision and approved the final version to be published.
Shanghai First Maternity and Infant Hospital, affiliated with Tongji University School of Medicine (2023B03 to Y.F., 2023B18 to X.Z., and 2020RC02 to Y.F.).
The authors declare no conflicts of interest.
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