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Programming by Estrogen Treatment in GnRH Antagonist Protocol

This study is not yet open for participant recruitment.
Verified August 2011 by Meir Medical Center
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01419353
First received: August 1, 2011
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.


Condition Intervention Phase
Infertility
 Drug: estradiol valerate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Programming by Estrogen Treatment in GnRH Antagonist Protocol

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • ovum pickup rate that took place between Sunday to Thursday without a compromise [ Time Frame: a year ] [ Designated as safety issue: No ]
    number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) devided by the entire pickup number


Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: a year ] [ Designated as safety issue: No ]
    comaprison of pregnancy rate between the 2 groups. calculated per cycle


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Follicular Estrogen, Antagonist, IVF
Follicular Estrogen in Antagonist IVF protocol
 Drug: estradiol valerate
2 mg P.O / day for 1-6 days.
Other Name: estradiol valerate
Active Comparator: long IVF protocol
long IVF protocol
 Drug: estradiol valerate
2 mg P.O / day for 1-6 days.
Other Name: estradiol valerate

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.

  Eligibility

Ages Eligible for Study:   up to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419353

Contacts
Contact: Anat Hershko-Klement, MD 97297472901 anat.klement@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel
Contact: Anat Hershko Klement, MD         anat.klement@gmail.com    
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Adrian Shulman, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Prof Adrian Shulman, Meir medical center
ClinicalTrials.gov Identifier: NCT01419353     History of Changes
Other Study ID Numbers: Antagonist_prog
Study First Received: August 1, 2011
Last Updated: August 17, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Infertility, IVF, Estrogen

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 16, 2013