Clinical trial NCT00615251: A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
Official title: A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: In vitro fertilization
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 1297
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
timeFrame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
Secondary outcomes:
measure: Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
timeFrame: Duration of study
measure: Adverse events
timeFrame: Duration of study
Other outcomes:
Locations:
city: Tarzana
country: United States
facility: Duramed Investigational Site
state: California
city: West Lake
country: United States
facility: Duramed Investigational Site
state: California
city: West Los Angeles
country: United States
facility: Duramed Investigational Site
state: California
city: Clearwater
country: United States
facility: Duramed Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Highland Park
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Rockville
country: United States
facility: Duramed Investigational Site
state: Maryland
city: Dearborn
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Flint
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Rochester Hills
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Ypsilanti
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Woodbury
country: United States
facility: Duramed Investigational Site
state: Minnesota
city: Reno
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Marlton
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Morristown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Cincinnati
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Duramed Investigational Site
state: Texas
city: Bedford
country: United States
facility: Duramed Investigational Site
state: Texas
city: Webster
country: United States
facility: Duramed Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Research Protocol Chair
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.