Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
Lead Sponsor:
Duramed Research
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE3
Brief Summary
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 approximat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1297 Patients enrolled
Trial Details
Trial ID
NCT00615251
Start Date
February 1 2008
End Date
August 1 2009
Last Update
September 13 2013
Active Locations (29)
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1
Duramed Investigational Site
Tarzana, California, United States, 91356
2
Duramed Investigational Site
West Los Angeles, California, United States, 90064
3
Duramed Investigational Site
Westlake, California, United States, 91361
4
Duramed Investigational Site
Clearwater, Florida, United States, 33759