Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
Overview
The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2013
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.
Interventions
- Drug: estradiol valerate
- 2 mg P.O / day for 1-6 days.
Arms, Groups and Cohorts
- Experimental: Follicular Estrogen, Antagonist, IVF
- Follicular Estrogen in Antagonist IVF protocol
- Active Comparator: long IVF protocol
- long IVF protocol
Clinical Trial Outcome Measures
Primary Measures
- ovum pickup rate that took place between Sunday to Thursday without a compromise
- Time Frame: a year
- number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \ by the entire pickup number
Secondary Measures
- pregnancy rate
- Time Frame: a year
- comparison of pregnancy rate between the 2 groups. calculated per cycle
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: N/A
Maximum Age: 38 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Meir Medical Center
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Adrian Shulman, MD, Study Chair, Meir Medical Center
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