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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