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

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Crinone 8% Vaginal Gel (Drug); Intramuscular Progesterone (Drug)

Phase: Phase 4

Status: Completed

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 (IVF) and Embryo Transfer (ET) Cycles in Women Under Age 40 Years Old

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Pregnant Patients After IVF Treatments

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
Additional Information

Starting date: July 2003
Last updated: September 20, 2011

Page last updated: August 23, 2015

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