Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Signed informed consent

• Patient age at time of embryo freezing: 18 to 40.9 years

• Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)

• Blastocysts frozen by vitrification at Brigham and Women's Hospital

• Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital

Exclusion Criteria:

• Fresh or cleavage-stage embryo transfer planned

• Gestational carrier cycles

• Natural and modified natural cycles

• Embryos frozen more than once or derived from thawed oocytes

• Embryos frozen at centers other than Brigham and Women's Hospital

• Embryos frozen using techniques other than vitrification (i.e. slow frozen)

• Patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies

• Uterine factor infertility: Asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx

• Patients with three prior failed embryo transfers (fresh or frozen)

• BMI<18 or >40 kg/m2 at screening

• Currently breast feeding or pregnant

• Embryo biopsy performed

• Current smoking, alcohol or illicit drug use

• Allergy to study drugs

• Refusal or inability to adhere to study protocol

• Participation in other experimental drug trials concurrently within the past 60 days