Overview

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Withdrawn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