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
Status: Recruiting
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
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).
Clinical Details
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
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).
Eligibility
Minimum age: 21 Years.
Maximum age: 39 Years.
Gender(s): Female.
Criteria:
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
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
Additional Information
Starting date: July 2003
Last updated: April 4, 2008
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