Back to resultsProgramming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
estradiol valerate
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, IVF, Estrogen
Eligibility Criteria
Inclusion Criteria:
- IVF treatment in the following indications: Male, Mechanical, Unexplained
- Age<38 years
- Treatment Cycle number 1-4
Exclusion Criteria:
- Ovulatory disorder as an indication for IVF
- Repeated failure in previous IVF treatments (> than 4 cycles)
- Sperm used for treatment was retrieved by surgical procedure
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Follicular Estrogen, Antagonist, IVF
long IVF protocol
Arm Description
Follicular Estrogen in Antagonist IVF protocol
long IVF protocol
Outcomes
Primary Outcome Measures
ovum pickup rate that took place between Sunday to Thursday without a compromise
number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \ by the entire pickup number
Secondary Outcome Measures
pregnancy rate
comparison of pregnancy rate between the 2 groups. calculated per cycle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01419353
Brief Title
Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
Official Title
Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.
Detailed Description
A randomised controlled trial in which study group will be given estrogen derivative before ovarian stimulation in GnRH antagonist protocol and compared to the classical GnRH agonist protocol.Estrogen will be given P.O , "PROGYNOVA' , in a dose of 2 mg /d, starting day 2 of menses and until first Monday to follow. Main outcome measure will be ability to control the ovum pickup day, calculated as a rate of ideal pickups divided by the entire pickup number. All women enrolled will be under 38 years of age, with a clear indication for IVF other than ovulatory dysfunction. women with past 4 treatment failures will be excluded as well as cases in which sperm achieved in surgical methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, IVF, Estrogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Follicular Estrogen, Antagonist, IVF
Arm Type
Experimental
Arm Description
Follicular Estrogen in Antagonist IVF protocol
Arm Title
long IVF protocol
Arm Type
Active Comparator
Arm Description
long IVF protocol
Intervention Type
Drug
Intervention Name(s)
estradiol valerate
Intervention Description
2 mg P.O / day for 1-6 days.
Primary Outcome Measure Information:
Title
ovum pickup rate that took place between Sunday to Thursday without a compromise
Description
number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \ by the entire pickup number
Time Frame
a year
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
comparison of pregnancy rate between the 2 groups. calculated per cycle
Time Frame
a year
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
IVF treatment in the following indications: Male, Mechanical, Unexplained
Age<38 years
Treatment Cycle number 1-4
Exclusion Criteria:
Ovulatory disorder as an indication for IVF
Repeated failure in previous IVF treatments (> than 4 cycles)
Sperm used for treatment was retrieved by surgical procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Shulman, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
25594526
Citation
Hershko Klement A, Berkovitz A, Wiser A, Gonen O, Amichay K, Cohen I, Ghetler Y, Shulman A. GnRH-antagonist programming versus GnRH agonist protocol: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:170-3. doi: 10.1016/j.ejogrb.2014.12.021. Epub 2014 Dec 29.
Results Reference
derived
Learn more about this trial
Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
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