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Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database.

Publication ,  Journal Article
Peipert, BJ; Spinosa, D; Howell, EP; Weber, JM; Truong, T; Harris, BS
Published in: Fertility and sterility
November 2021

To characterize the interventional clinical trials in infertility and to assess whether trial location or industry sponsorship was associated with trial noncompletion.Retrospective review of trials registered with ClinicalTrials.gov.None.None.None.Descriptive statistics characterizing the attributes of the clinical trials including intervention type, topic, population, completion status, size, location, sponsor, and results. The effects of the sponsor and trial location on trial noncompletion were assessed via logistic regression.In total, 505 trials initiated between 2010 and 2020 were included in our analysis. Drug interventions were the most commonly studied (45%); ovarian stimulation trials accounted for 27% of the studies. Live birth was tracked as an outcome by 20% of the studies; 3% of the trials included mental health outcomes. Few trials (15%) enrolled male participants. Only 11% of the trials reported results, and 4% of the trials reported the race or ethnicity of the participants. Most trials (82%) were conducted outside the United States. Overall, 18% of the trials were not completed, most often because of lack of accrual (47%). United States trials had over twice the odds of noncompletion in univariate analysis (odds ratio = 2.48, 95% confidence interval = [1.47, 4.17]); however, this relationship lost significance after adjusting for potential confounders (odds ratio = 0.95, 95% confidence interval = [0.42, 2.14]). Trial sponsorship was not associated with trial noncompletion.Infertility trials predominantly investigated drug interventions, particularly ovarian stimulation. Live birth was an infrequent outcome despite its relevance to patients. Clinical trials should aim to address the unmet needs in fertility care and be inclusive of underserved populations affected by infertility.

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Published In

Fertility and sterility

DOI

EISSN

1556-5653

ISSN

0015-0282

Publication Date

November 2021

Volume

116

Issue

5

Start / End Page

1381 / 1390

Related Subject Headings

  • Treatment Outcome
  • Retrospective Studies
  • Research Support as Topic
  • Research Design
  • Reproductive Techniques, Assisted
  • Reproductive Medicine
  • Pregnancy Rate
  • Pregnancy
  • Obstetrics & Reproductive Medicine
  • Multicenter Studies as Topic
 

Citation

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Peipert, B. J., Spinosa, D., Howell, E. P., Weber, J. M., Truong, T., & Harris, B. S. (2021). Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database. Fertility and Sterility, 116(5), 1381–1390. https://doi.org/10.1016/j.fertnstert.2021.06.013
Peipert, Benjamin J., Daniel Spinosa, Elizabeth P. Howell, Jeremy M. Weber, Tracy Truong, and Benjamin S. Harris. “Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database.Fertility and Sterility 116, no. 5 (November 2021): 1381–90. https://doi.org/10.1016/j.fertnstert.2021.06.013.
Peipert BJ, Spinosa D, Howell EP, Weber JM, Truong T, Harris BS. Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database. Fertility and sterility. 2021 Nov;116(5):1381–90.
Peipert, Benjamin J., et al. “Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database.Fertility and Sterility, vol. 116, no. 5, Nov. 2021, pp. 1381–90. Epmc, doi:10.1016/j.fertnstert.2021.06.013.
Peipert BJ, Spinosa D, Howell EP, Weber JM, Truong T, Harris BS. Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database. Fertility and sterility. 2021 Nov;116(5):1381–1390.
Journal cover image

Published In

Fertility and sterility

DOI

EISSN

1556-5653

ISSN

0015-0282

Publication Date

November 2021

Volume

116

Issue

5

Start / End Page

1381 / 1390

Related Subject Headings

  • Treatment Outcome
  • Retrospective Studies
  • Research Support as Topic
  • Research Design
  • Reproductive Techniques, Assisted
  • Reproductive Medicine
  • Pregnancy Rate
  • Pregnancy
  • Obstetrics & Reproductive Medicine
  • Multicenter Studies as Topic