Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Crinone 8% Vaginal Gel; Drug: Intramuscular Progesterone

• Registration Number: NCT00656201
• Lead Sponsor: Brigham and Women's Hospital

Brief 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).

Detailed Description

The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2008-11
• Study Completion: 2009-07
• Results First Submitted: 2011-06-27
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-19
• Results First Posted: 2011-09-20
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 468

Inclusion Criteria

• Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH < 15 mIU/ml
• Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

Exclusion Criteria

• Women who have had more than 3 previous IVF/ET cycles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crinone 8% Vaginal Gel	Crinone 8% Vaginal Gel	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 Progesterone	Intramuscular Progesterone	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. .

Primary Outcome Measures

Name	Time	Method
Percentage of Pregnant Patients After IVF Treatments	16 weeks	Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States