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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 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 900 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01044862
The ClinicalTrials.gov registry entry for NCT01044862 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Clomiphene Citrate is the first listed.
NCT01044862 reports 0 study locations.
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.
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