Infertility Clinical Trial
Official title:
A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.
Status | Completed |
Enrollment | 1297 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
Inclusion Criteria: - Pre-menopausal, aged 18-42 old at time of consent - At least one cycle without fertility medication prior to screening - Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility - Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria) - Others as indicated by FDA-approved protocol Exclusion Criteria: - Any contraindication to progesterone therapy - BMI > 38 kg/m2 - Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others) - History of more than 1 failed fresh IVF cycles - More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound) - Others as indicated by FDA-approved protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duramed Investigational Site | Alpharetta | Georgia |
United States | Duramed Investigational Site | Atlanta | Georgia |
United States | Duramed Investigational Site | Austin | Texas |
United States | Duramed Investigational Site | Beaumont | Texas |
United States | Duramed Investigational Site | Bedford | Texas |
United States | Duramed Investigational Site | Boise | Idaho |
United States | Duramed Investigational Site | Chicago | Illinois |
United States | Duramed Investigational Site | Cincinnati | Ohio |
United States | Duramed Investigational Site | Clearwater | Florida |
United States | Duramed Investigational Site | Columbia | South Carolina |
United States | Duramed Investigational Site | Dearborn | Michigan |
United States | Duramed Investigational Site | Flint | Michigan |
United States | Duramed Investigational Site | Highland Park | Illinois |
United States | Duramed Investigational Site | Marlton | New Jersey |
United States | Duramed Investigational Site | Morristown | New Jersey |
United States | Duramed Investigational Site | Mount Pleasant | South Carolina |
United States | Duramed Investigational Site | Myrtle Beach | South Carolina |
United States | Duramed Investigational Site | Norfolk | Virginia |
United States | Duramed Investigational Site | Reno | Nevada |
United States | Duramed Investigational Site | Rochester Hills | Michigan |
United States | Duramed Investigational Site | Rockville | Maryland |
United States | Duramed Investigational Site | Saginaw | Michigan |
United States | Duramed Investigational Site | Sylvania | Ohio |
United States | Duramed Investigational Site | Tarzana | California |
United States | Duramed Investigational Site | Webster | Texas |
United States | Duramed Investigational Site | West Lake | California |
United States | Duramed Investigational Site | West Los Angeles | California |
United States | Duramed Investigational Site | Woodbury | Minnesota |
United States | Duramed Investigational Site | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Duramed Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy | 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval) | No | |
Secondary | Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy | Duration of study | No | |
Secondary | Adverse events | Duration of study | Yes |
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