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Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Crinone 8% Vaginal Gel
Intramuscular Progesterone
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, In vitro fertilization, Embryo transfer, Crinone, Intramuscular Progesterone, Progesterone support

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH < 15 mIU/ml
  • Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

Exclusion Criteria:

  • Women who have had more than 3 previous IVF/ET cycles

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Crinone 8% Vaginal Gel

Intramuscular Progesterone

Arm Description

Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.

Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy. .

Outcomes

Primary Outcome Measures

Percentage of Pregnant Patients After IVF Treatments
Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval

Secondary Outcome Measures

Full Information

First Posted
April 4, 2008
Last Updated
September 20, 2011
Sponsor
Brigham and Women's Hospital
Collaborators
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT00656201
Brief Title
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)
Official Title
Comparison of Crinone 8% Intravaginal Gel or Intramuscular Progesterone Supplementation for In Vitro Fertilization (IVF) and Embryo Transfer (ET) Cycles in Women Under Age 40 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
EMD Serono

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).
Detailed Description
The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, In vitro fertilization, Embryo transfer, Crinone, Intramuscular Progesterone, Progesterone support

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crinone 8% Vaginal Gel
Arm Type
Active Comparator
Arm Description
Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
Arm Title
Intramuscular Progesterone
Arm Type
Active Comparator
Arm Description
Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy. .
Intervention Type
Drug
Intervention Name(s)
Crinone 8% Vaginal Gel
Other Intervention Name(s)
IVF-ET, Pregnancy, luteal phase support, Crinone, Intramuscular progesterone, vaginal progesterone
Intervention Description
Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
Intervention Type
Drug
Intervention Name(s)
Intramuscular Progesterone
Other Intervention Name(s)
Other Names:, IVF-ET, Pregnancy, luteal phase support, Crinone, vaginal progesterone
Intervention Description
Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
Primary Outcome Measure Information:
Title
Percentage of Pregnant Patients After IVF Treatments
Description
Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH < 15 mIU/ml Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG. Exclusion Criteria: Women who have had more than 3 previous IVF/ET cycles
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena H Yanushpolsky, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20347079
Citation
Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27.
Results Reference
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Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

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