A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

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 approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duramed Research
• Treatments: Progesterone

Criteria

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