A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
NCT ID: NCT00615251
Last Updated: 2013-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1297 participants
INTERVENTIONAL
2008-02-29
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
DR-2011
Progesterone vaginal ring for approximately 10 weeks
2
Crinone 8%
progesterone vaginal gel for approximately 10 weeks
Interventions
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DR-2011
Progesterone vaginal ring for approximately 10 weeks
Crinone 8%
progesterone vaginal gel for approximately 10 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
42 Years
FEMALE
Yes
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Principal Investigators
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Duramed Research Protocol Chair
Role: STUDY_CHAIR
Duramed Research, Inc.
Locations
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Duramed Investigational Site
Tarzana, California, United States
Duramed Investigational Site
West Los Angeles, California, United States
Duramed Investigational Site
Westlake, California, United States
Duramed Investigational Site
Clearwater, Florida, United States
Duramed Investigational Site
Alpharetta, Georgia, United States
Duramed Investigational Site
Atlanta, Georgia, United States
Duramed Investigational Site
Boise, Idaho, United States
Duramed Investigational Site
Chicago, Illinois, United States
Duramed Investigational Site
Highland Park, Illinois, United States
Duramed Investigational Site
Rockville, Maryland, United States
Duramed Investigational Site
Dearborn, Michigan, United States
Duramed Investigational Site
Flint, Michigan, United States
Duramed Investigational Site
Rochester Hills, Michigan, United States
Duramed Investigational Site
Saginaw, Michigan, United States
Duramed Investigational Site
Ypsilanti, Michigan, United States
Duramed Investigational Site
Woodbury, Minnesota, United States
Duramed Investigational Site
Reno, Nevada, United States
Duramed Investigational Site
Marlton, New Jersey, United States
Duramed Investigational Site
Morristown, New Jersey, United States
Duramed Investigational Site
Cincinnati, Ohio, United States
Duramed Investigational Site
Sylvania, Ohio, United States
Duramed Investigational Site
Columbia, South Carolina, United States
Duramed Investigational Site
Mt. Pleasant, South Carolina, United States
Duramed Investigational Site
Myrtle Beach, South Carolina, United States
Duramed Investigational Site
Austin, Texas, United States
Duramed Investigational Site
Beaumont, Texas, United States
Duramed Investigational Site
Bedford, Texas, United States
Duramed Investigational Site
Webster, Texas, United States
Duramed Investigational Site
Norfolk, Virginia, United States
Countries
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References
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Ginsburg ES, Jellerette-Nolan T, Daftary G, Du Y, Silverberg KM. Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization. Fertil Steril. 2018 Nov;110(6):1101-1108.e3. doi: 10.1016/j.fertnstert.2018.07.014.
Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.
Other Identifiers
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DR-PGN-302
Identifier Type: -
Identifier Source: org_study_id
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