Trial Outcomes & Findings for Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF) (NCT NCT00656201)

Last Updated: 2011-09-22

Results Overview

Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

468 participants

Primary outcome timeframe

16 weeks

Results posted on

2011-09-22

Participant Flow

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.

The participant may not qualify for enrollment if there were no eggs fertilized, or no embryos transfered, or all embryos frozen.

Participant milestones

Participant milestones
Measure	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.	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. .
Overall Study STARTED	235	233
Overall Study COMPLETED	206	201
Overall Study NOT COMPLETED	29	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crinone 8% Vaginal Gel n=235 Participants 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.	Intramuscular Progesterone n=233 Participants 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. .	Total n=468 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	235 Participants n=5 Participants	233 Participants n=7 Participants	468 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34.0 years STANDARD_DEVIATION 3.3 • n=5 Participants	34.2 years STANDARD_DEVIATION 3.5 • n=7 Participants	34.1 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	235 Participants n=5 Participants	233 Participants n=7 Participants	468 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	235 participants n=5 Participants	233 participants n=7 Participants	468 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval

Outcome measures

Outcome measures
Measure	Crinone 8% Vaginal Gel n=206 Participants 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.	Intramuscular Progesterone n=201 Participants 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. .
Percentage of Pregnant Patients After IVF Treatments	66 percentage of participants Interval 80.0 to 180.0	62 percentage of participants Interval 80.0 to 180.0

Adverse Events

Crinone 8% Vaginal Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intramuscular Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elena Yanushpolsky, MD

Brigham and Women's Hospital

Phone: 617-732-4648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place