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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
History of Changes
  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:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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
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, Male
Genital Diseases, Female
Progesterone
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013