Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020

Jecca R Steinberg, Christopher J Magnani, Brandon E Turner, Brannon T Weeks, Anna Marie P Young, Connie Fei Lu, Naixin Zhang, Michael Taylor Richardson, Alison Conway Fitzgerald, Zesemayat Mekonnen, Tene Redman, Modupe Adetunji, Shanique A Martin, Jill N Anderson, Katelyn S Chan, Magdy P. Milad
Obstetrics and gynecology · · vol. 139(5) , pp. 821–831 · doi:10.1097/AOG.0000000000004735 · PMID:35576341
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⚙ AI-generated summary by gemini-2.5-flash-lite, 2026-06-08 ⓘ

Gynecology trials, comprising 3.7% of all clinical trials, demonstrate poor results reporting and publication rates, with industry-funded and certain subspecialty trials showing higher discontinuation or lower reporting likelihoods.

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This cross-sectional study analyzed 8,174 gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 to evaluate rates of early discontinuation, results reporting, and publication. The authors found that gynecology trials represent only 3.7% of all clinical trials, with academic funding associated with lower results reporting but higher publication likelihood compared to other sources. Reproductive endocrinology and infertility trials showed the highest rates of early termination and lowest rates of results dissemination among subspecialties, highlighting significant gaps in data transparency. Relevance to endometriosis: listed as one of the benign gynecology conditions encompassed by the "other benign gynecology" category in this broad epidemiological analysis of trial outcomes.

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Abstract

OBJECTIVE: To characterize gynecology clinical trials over time, compare gynecology subspecialties, and analyze factors associated with early discontinuation, results reporting, and publication. METHODS: We conducted a cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications. Trials were analyzed with descriptive, multivariable logistic, and Cox regression analyses. Primary exposure variables were trial funding and subspecialty. The three primary outcomes included early discontinuation, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed. RESULTS: Of 223,690 trials registered on ClinicalTrials.gov between October 2007 and March 2020, only 3.7% focused on gynecology (n=8,174, approximately 3,759,086 participants). Subspecialties included reproductive endocrinology and infertility (n=1,428, 17.5%), gynecologic oncology (n=2,063, 25.2%), urogynecology (n=1,118, 13.7%), family planning (n=648, 7.9%), and other benign gynecology (n=2,917, 35.7%). Only 42.0% of completed trials disseminated results through results reporting and publication. Of all funding types, industry-funded trials were the most likely to be discontinued early (P<.001). Academic-funded trials were the least likely to report results (adjusted odds ratio [aOR] 0.38, 95% CI 0.30-0.50) but the most likely to publish (aOR 1.62, 95% CI 1.24-2.12). The number of reproductive endocrinology and infertility trials increased the most of any subspecialty between 2007 and 2020 (6.4% growth rate). Reproductive endocrinology and infertility and family planning trials were the most likely to be stopped early (reproductive endocrinology and infertility: adjusted hazard ratio [aHR] 2.08, 95% CI 1.59-2.71; family planning: aHR 1.55 95% CI 1.06-2.25). When completed, reproductive endocrinology and infertility trials were the least likely to report results (aOR 0.58, 95% CI 0.38-0.88). No significant differences were seen between subspecialties with respect to publication. CONCLUSION: Gynecology trials comprise only 3.7% of all clinical trials. The paucity of gynecology clinical trials aligns with decades of female underrepresentation in research. When completed, gynecology trials have poor dissemination. Our findings raise concern about bias in the performance, reporting, and publication of gynecology clinical trials.
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Objective

To characterize gynecology clinical trials over time, compare gynecology subspecialties, and analyze factors associated with early discontinuation, results reporting, and publication.

Methods

We conducted a cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications. Trials were analyzed with descriptive, multivariable logistic, and Cox regression analyses. Primary exposure variables were trial funding and subspecialty. The three primary outcomes included early discontinuation, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed.

Results

Of 223,690 trials registered on ClinicalTrials.gov between October 2007 and March 2020, only 3.7% focused on gynecology (n=8,174, approximately 3,759,086 participants). Subspecialties included reproductive endocrinology and infertility (n=1,428, 17.5%), gynecologic oncology (n=2,063, 25.2%), urogynecology (n=1,118, 13.7%), family planning (n=648, 7.9%), and other benign gynecology (n=2,917, 35.7%). Only 42.0% of completed trials disseminated results through results reporting and publication. Of all funding types, industry-funded trials were the most likely to be discontinued early (P<.001). Academic-funded trials were the least likely to report results (adjusted odds ratio [aOR] 0.38, 95% CI 0.30–0.50) but the most likely to publish (aOR 1.62, 95% CI 1.24–2.12). The number of reproductive endocrinology and infertility trials increased the most of any subspecialty between 2007 and 2020 (6.4% growth rate). Reproductive endocrinology and infertility and family planning trials were the most likely to be stopped early (reproductive endocrinology and infertility: adjusted hazard ratio [aHR] 2.08, 95% CI 1.59–2.71; family planning: aHR 1.55 95% CI 1.06–2.25). When completed, reproductive endocrinology and infertility trials were the least likely to report results (aOR 0.58, 95% CI 0.38–0.88). No significant differences were seen between subspecialties with respect to publication.

Conclusion

Gynecology trials comprise only 3.7% of all clinical trials. The paucity of gynecology clinical trials aligns with decades of female underrepresentation in research. When completed, gynecology trials have poor dissemination. Our findings raise concern about bias in the performance, reporting, and publication of gynecology clinical trials. Gynecology trials comprise less than 4% of all trials, often are discontinued early, and infrequently report results or publish.

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Condition tags

infertility

MeSH descriptors

Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Gynecology Infertility Infertility Infertility Infertility

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