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

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: DR-2011; Drug: Crinone 8%

• Registration Number: NCT00615251
• Lead Sponsor: Duramed Research

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-14
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Disposition First Submitted: 2011-06-08
• Disposition First Submitted QC: 2011-06-08
• Disposition First Posted: 2011-06-22
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-30
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1297

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DR-2011	-
2	Crinone 8%	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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
Adverse events	Duration of study

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Norfolk, Virginia, United States