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Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419353
First Posted: August 18, 2011
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

Resource links provided by NLM:


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 ]
    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 [ Time Frame: a year ]
    comparison of pregnancy rate between the 2 groups. calculated per cycle


Enrollment: 63
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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.
Active Comparator: long IVF protocol
long IVF protocol
Drug: estradiol valerate
2 mg P.O / day for 1-6 days.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 38 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419353


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Adrian Shulman, MD Meir Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01419353     History of Changes
Other Study ID Numbers: Antagonist_prog
First Submitted: August 1, 2011
First Posted: August 18, 2011
Last Update Posted: December 24, 2013
Last Verified: August 2011

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

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