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NCT Number: NCT00615251

A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Tarzana, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-2011

Drug

Progesterone vaginal ring for approximately 10 weeks

Crinone 8%

Drug

progesterone vaginal gel for approximately 10 weeks

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Adverse events

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 14, 2008
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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