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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Crinone 8% Vaginal Gel; Drug: Intramuscular Progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00656201

BWH 2003p000075

Details and patient eligibility

About

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

Full 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).

Enrollment: 468 patients

Sex: Female

Ages: 21 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

468 participants in 2 patient groups

Crinone 8% Vaginal Gel

Active Comparator group

Description:

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.

Treatment:

Drug: Crinone 8% Vaginal Gel

Intramuscular Progesterone

Active Comparator group

Description:

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. .

Treatment:

Drug: Intramuscular Progesterone