CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 900 enrolled
Drug / intervention
Letrozole (aromatase inhibitor) +2 moredrug
Likely dose
Letrozole (aromatase inhibitor) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01044862
NCT01044862Phase 3Completed
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Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation

Yale University·interventional·Posted Jan 8, 2010·Updated Feb 2, 2015

In Brief

A Phase 3 clinical trial evaluating Letrozole (aromatase inhibitor), Clomiphene Citrate, and 1 other intervention for Pregnancy and Unexplained Infertility. Completed, enrolled 900 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Unexplained Infertility
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2010
Enrollment StartJun 1, 2010
Primary CompletionOct 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.5 years ago

Interventions

Letrozole (aromatase inhibitor)drug

A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.

Clomiphene Citratedrug

CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.

Follicle Stimulating Hormone (gonadotropin)drug

A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.