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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,297
Progesterone vaginal ring for approximately 10 weeks
progesterone vaginal gel for approximately 10 weeks
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
Time frame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Time frame: Duration of study
Adverse events
Time frame: Duration of study
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West Los Angeles, California, United States
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