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Completed

NCT Number: NCT00656201

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this 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 progesterone).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crinone 8% Vaginal Gel

Drug

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

Intramuscular Progesterone

Drug

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, vaginal progesterone

Primary outcomes

  1. Percentage of Pregnant Patients After IVF Treatments

    Time frame: 16 weeks

    Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • EMD Serono

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Apr 10, 2008
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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