Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Crinone 8% Vaginal Gel and Intramuscular Progesterone (Drug)
Phase: Phase 4
Sponsored by: Brigham and Women's Hospital
Official(s) and/or principal investigator(s):
Elena H Yanushpolsky, M.D., Principal Investigator, Affiliation: Brigham and Women's Hospital
The goal of this research study is to compare the pregnancy rates for two different types of
progesterone supplementation after in-vitro fertilization (IVF).
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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: The primary study endpoint is the difference in pregnancy rates in the two arms of the study
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
Minimum age: 21 Years.
Maximum age: 39 Years.
- 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.
- Women who have had more than 3 previous IVF/ET cycles
Locations and Contacts
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Louise R Greenberg, M.Ed., Phone: 617-732-5441, Ext: -, Email: Lgreenberg@partners.org
Elena H Yanushpolsky, M.D., Phone: 617-732-4648, Ext: -, Email: Eyanushpolsky@partners.org
Elena H Yanushpolsky, M.D., Principal Investigator
Starting date: July 2003
Last updated: April 4, 2008