Infertility
Conditions
Keywords
Infertility, In vitro fertilization, Embryo transfer, Blastocyst, Progesterone, Crinone
Brief 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).
Detailed description
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).
Interventions
DRUGVaginal progesterone gel (Crinone® 8%)
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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 5-6 weeks | Percentage of patients with intrauterine gestational sac by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 5-6 weeks | Maximum number of gestational sacs divided by total number of embryos transferred |
| Sustained implantation rate | 7 weeks | maximum number of fetal heartbeats divided by total number of embryos transferred |
| Biochemical pregnancy | 6 weeks | Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy |
| Ongoing pregnancy rate | 7-8 weeks | Live intrauterine pregnancy at the time of transfer to obstetrical care |
Countries
United States
Outcome results
None listed