Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: estradiol valerate

• Registration Number: NCT01419353
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Follicular Estrogen, Antagonist, IVF	estradiol valerate	Follicular Estrogen in Antagonist IVF protocol
long IVF protocol	estradiol valerate	long IVF protocol

Primary Outcome Measures

Name	Time	Method
ovum pickup rate that took place between Sunday to Thursday without a compromise	a year	number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \\ by the entire pickup number

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	a year	comparison of pregnancy rate between the 2 groups. calculated per cycle

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel