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

Journal Article (Journal Article)

Objective

To characterize the interventional clinical trials in infertility and to assess whether trial location or industry sponsorship was associated with trial noncompletion.

Design

Retrospective review of trials registered with ClinicalTrials.gov.

Setting

None.

Patient(s)

None.

Intervention(s)

None.

Main outcome measure(s)

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.

Result(s)

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.

Conclusion(s)

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.

Full Text

Duke Authors

Cited Authors

  • Peipert, BJ; Spinosa, D; Howell, EP; Weber, JM; Truong, T; Harris, BS

Published Date

  • November 2021

Published In

Volume / Issue

  • 116 / 5

Start / End Page

  • 1381 - 1390

PubMed ID

  • 34256949

Electronic International Standard Serial Number (EISSN)

  • 1556-5653

International Standard Serial Number (ISSN)

  • 0015-0282

Digital Object Identifier (DOI)

  • 10.1016/j.fertnstert.2021.06.013

Language

  • eng