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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DR-2011
Crinone 8%
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In vitro fertilization

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy

Secondary Outcome Measures

Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Adverse events

Full Information

First Posted
February 4, 2008
Last Updated
August 30, 2013
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00615251
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In vitro fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DR-2011
Intervention Description
Progesterone vaginal ring for approximately 10 weeks
Intervention Type
Drug
Intervention Name(s)
Crinone 8%
Intervention Description
progesterone vaginal gel for approximately 10 weeks
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Adverse events
Time Frame
Duration of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Research Protocol Chair
Organizational Affiliation
Duramed Research, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Duramed Investigational Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Duramed Investigational Site
City
West Lake
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Duramed Investigational Site
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States
Facility Name
Duramed Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Duramed Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Duramed Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Duramed Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Duramed Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Duramed Investigational Site
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Duramed Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Duramed Investigational Site
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Duramed Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Duramed Investigational Site
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Duramed Investigational Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Duramed Investigational Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Duramed Investigational Site
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Duramed Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Duramed Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Duramed Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Duramed Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45209
Country
United States
Facility Name
Duramed Investigational Site
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Duramed Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Duramed Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Duramed Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29577
Country
United States
Facility Name
Duramed Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Duramed Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Facility Name
Duramed Investigational Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Duramed Investigational Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Duramed Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30396554
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.
Results Reference
derived
PubMed Identifier
23465817
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.
Results Reference
derived

Learn more about this trial

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

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