At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 468 enrolled

Drug / intervention

Crinone 8% Vaginal Gel +1 moredrug

Likely dose

Crinone 8% Vaginal Gel 90 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/NCT00656201

NCT00656201Phase 4Completed

Compare CT.gov

Comparison of Crinone 8% Intravaginal Gel or Intramuscular Progesterone Supplementation for In Vitro Fertilization (IVF) and Embryo Transfer (ET) Cycles in Women Under Age 40 Years Old

Brigham and Women's Hospital·interventional·Posted Apr 10, 2008·Updated Sep 22, 2011

In Brief

A Phase 4 clinical trial evaluating Crinone 8% Vaginal Gel and Intramuscular Progesterone for Infertility. Completed, enrolled 468 participants across 1 site.

Detailed Summary

The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfertility

CountriesUnited States

CollaboratorsEMD Serono

Timeline

Phase 4CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2003

First PostedApr 2008

Primary CompletionNov 2008

Study CompletionJul 2009

TodayJul 2026

First PostedApr 10, 2008

Enrollment StartJul 1, 2003

Primary CompletionNov 1, 2008

Study CompletionJul 1, 2009

TodayJul 2, 2026

Enrollment to primary: 5.3 yearsPosted 18.2 years ago

Interventions

Crinone 8% Vaginal Geldrug

Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.

Intramuscular Progesteronedrug

Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.