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Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

NCT ID: NCT01419353

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Infertility

Keywords

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Infertility, IVF, Estrogen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Follicular Estrogen, Antagonist, IVF

Follicular Estrogen in Antagonist IVF protocol

Group Type EXPERIMENTAL

estradiol valerate

Intervention Type DRUG

2 mg P.O / day for 1-6 days.

long IVF protocol

long IVF protocol

Group Type ACTIVE_COMPARATOR

estradiol valerate

Intervention Type DRUG

2 mg P.O / day for 1-6 days.

Interventions

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estradiol valerate

2 mg P.O / day for 1-6 days.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Shulman, MD

Role: STUDY_CHAIR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, Israel, Israel

Site Status

Countries

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Israel

References

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Hershko Klement A, Berkovitz A, Wiser A, Gonen O, Amichay K, Cohen I, Ghetler Y, Shulman A. GnRH-antagonist programming versus GnRH agonist protocol: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:170-3. doi: 10.1016/j.ejogrb.2014.12.021. Epub 2014 Dec 29.

Reference Type DERIVED
PMID: 25594526 (View on PubMed)

Other Identifiers

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Antagonist_prog

Identifier Type: -

Identifier Source: org_study_id