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

This study has been completed.
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Elena Hesina Yanushpolsky, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00656201
First received: April 4, 2008
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).


Condition Intervention Phase
Infertility
Drug: Crinone 8% Vaginal Gel
Drug: Intramuscular Progesterone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Percentage of Pregnant Patients After IVF Treatments [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval


Enrollment: 468
Study Start Date: July 2003
Study Completion Date: July 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Names:
  • IVF-ET
  • Pregnancy
  • luteal phase support
  • Crinone
  • Intramuscular progesterone
  • vaginal progesterone
Active Comparator: 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.

.

Drug: 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.
Other Names:
  • Other Names:
  • IVF-ET
  • Pregnancy
  • luteal phase support
  • Crinone
  • Intramuscular progesterone
  • vaginal progesterone

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

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656201

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
EMD Serono
Investigators
Principal Investigator: Elena H Yanushpolsky, M.D. Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Elena Hesina Yanushpolsky, MD, Assistant Professor of Ob/Gyn, BWH and Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00656201     History of Changes
Other Study ID Numbers: BWH 2003p000075
Study First Received: April 4, 2008
Results First Received: June 27, 2011
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Infertility
In vitro fertilization
Embryo transfer
Crinone
Intramuscular Progesterone
Progesterone support

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on October 20, 2014