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NCT01044862 · ClinicalTrials.gov registry record · Phase 3

Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation

A Phase 3 study, sponsored by Yale University.

Completed
Registry status
Phase 3
Development phase
900
Enrollment target

NCT01044862: Completed Phase 3 study, sponsored by Yale University.

NCT01044862 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 900 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01044862, a Phase 3 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 3
Development phase
900 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Clomiphene Citrate
  • DRUG Letrozole (aromatase inhibitor)
  • DRUG Follicle Stimulating Hormone (gonadotropin)

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2010-06
Est. Completion 2014-03
Phase Phase 3
Yale University

1,492 total trials

What the finished NCT01044862 record still lists

NCT01044862 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 3 interventions - of which Clomiphene Citrate is the first listed.

NCT01044862 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01044862 about?

NCT01044862 is a clinical study titled "Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation". 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 inferti...

What is the current status of trial NCT01044862?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2010-06. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01044862?

The interventions under investigation include: Clomiphene Citrate (DRUG), Letrozole (aromatase inhibitor) (DRUG), Follicle Stimulating Hormone (gonadotropin) (DRUG).

Who is sponsoring clinical trial NCT01044862?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01044862's enrollment target sits among peer trials

900 350th of 2000 higher than 1,641 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01044862, the US trial registry maintained by the National Library of Medicine. NCT01044862 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.