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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.
Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical pregnancy rate
Percentage of patients with intrauterine gestational sac by ultrasound
Time frame: 5-6 weeks
Implantation rate
Maximum number of gestational sacs divided by total number of embryos transferred
Time frame: 5-6 weeks
Sustained implantation rate
maximum number of fetal heartbeats divided by total number of embryos transferred
Time frame: 7 weeks
Biochemical pregnancy
Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy
Time frame: 6 weeks
Ongoing pregnancy rate
Live intrauterine pregnancy at the time of transfer to obstetrical care
Time frame: 7-8 weeks
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