Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles
| Status: | Suspended |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/30/2018 |
Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles
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).
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).
The hypothesis of this study is that the type of progesterone administered (intramuscular
progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy
rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and
frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or
vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase
support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for
progesterone supplementation or replacement as part of an Assisted Reproductive Technology
(ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).
progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy
rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and
frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or
vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase
support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for
progesterone supplementation or replacement as part of an Assisted Reproductive Technology
(ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).
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
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