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Clinical trialNCT01044862CompletedPhase 3Interventional

Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation

SponsorYale UniversityEnrollment900PregnancyUnexplained Infertility
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The objective of this application is to identify a pharmacologic agent which helps couples in whom the female partner ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. The central hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed research is that reduction of multiple pregnancy rates could significantly reduce maternal and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals and society.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama Birmingham

    Birmingham, Alabama, United States

  • University of California, San Francisco

    San Francisco, California, United States

  • Stanford University Medical Center

    Stanford, California, United States

  • University of Colorado

    Aurora, Colorado, United States

  • Yale University

    New Haven, Connecticut, United States

  • University of Michigan

    Ann Arbor, Michigan, United States

  • Wayne State University

    Detroit, Michigan, United States

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States

  • Pennsylvania State University College of Medicine

    Hershey, Pennsylvania, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, United States

  • University of Vermont

    Burlington, Vermont, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ClomipheneFollicle stimulating hormoneLetrozole
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2010
Primary completion
31 Oct 2013
Completion
31 Mar 2014
Last update posted
2 Feb 2015
Registered enrollment
900
Registry id
NCT01044862

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.