Official Title: “Comparison of Crinone 8% Intravaginal Gel or Intramuscular Progesterone Supplementation for In Vitro Fertilization and Embryo Transfer Cycles in Women Under Age 40 Years Old”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2008

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).

Intervention(s) in this Clinical Trial

• Drug: Crinone 8% Vaginal Gel and Intramuscular Progesterone
  • 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. 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 (Group B).

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • 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.
• Active Comparator: B
  • 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 Measures

• The primary study endpoint is the difference in pregnancy rates in the two arms of the study
  • Time Frame: The data analysis will take place when 400 subjects have completed the study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 39 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Brigham and Women's Hospital

Overall Clinical Trial Officials and Contacts

Elena H Yanushpolsky, M.D. Principal Investigator Brigham and Women's Hospital  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00656201

Study ID Number: BWH 2003p000075

ClinicalTrials.gov Identifier: NCT00656201

Health Authority: United States: Institutional Review Board