Infertility
Conditions
Keywords
Infertility, In vitro fertilization, Embryo transfer, Crinone, Intramuscular Progesterone, Progesterone support
Brief summary
The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).
Detailed description
The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).
Interventions
Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
Sponsors
EMD Serono
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH \< 15 mIU/ml * Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.
Exclusion criteria
* Women who have had more than 3 previous IVF/ET cycles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Pregnant Patients After IVF Treatments | 16 weeks | Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval |
Countries
United States
Participant flow
Recruitment details
All patients starting an IVF cycle will receive a letter from their physician and Dr. Yanushpolsky. We will include a copy of the consent form. This letter will briefly describe the study and will have an opt out paragraph. Patients fulfilling inc/exc criteria will be approached on the day of their oocyte retrieval by a study coordinator.
Pre-assignment details
The participant may not qualify for enrollment if there were no eggs fertilized, or no embryos transfered, or all embryos frozen.
Participants by arm
| Arm | Count |
|---|---|
| Crinone 8% Vaginal Gel Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. | 235 |
| Intramuscular Progesterone Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
. | 233 |
| Total | 468 |
Baseline characteristics
| Characteristic | Intramuscular Progesterone | Crinone 8% Vaginal Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 233 Participants | 235 Participants | 468 Participants |
| Age Continuous | 34.2 years STANDARD_DEVIATION 3.5 | 34.0 years STANDARD_DEVIATION 3.3 | 34.1 years STANDARD_DEVIATION 3.4 |
| Region of Enrollment United States | 233 participants | 235 participants | 468 participants |
| Sex: Female, Male Female | 233 Participants | 235 Participants | 468 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 206 | 0 / 201 |
| serious Total, serious adverse events | 0 / 206 | 0 / 201 |
Outcome results
Primary
Percentage of Pregnant Patients After IVF Treatments
Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval
Time frame: 16 weeks
Population: Number of participants for analysis was determined by completion of the IVF cycle using the specified medications, either Crinone or IM Progesterone
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crinone 8% Vaginal Gel | Percentage of Pregnant Patients After IVF Treatments | 66 percentage of participants |
| Intramuscular Progesterone | Percentage of Pregnant Patients After IVF Treatments | 62 percentage of participants |
p-value: <0.0595% CI: [0.8, 1.8]Wilcoxon (Mann-Whitney)