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

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.

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