Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

NCT ID: NCT02173977

Last Updated: 2014-06-25

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol.

The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

Detailed Description

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The ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist.

The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS).

The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol

1\. To compare the IVF outcome variables and ongoing pregnancy rates.

Conditions

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Infertility

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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ARM A- Agonist/Antagonist protocol

The Ultrashort GnRH Agonist/antagonist method entails pre-treatment with oral contraceptive pills before the combination of GnRH ultrashort agonist and antagonist protocol

Group Type ACTIVE_COMPARATOR

ARM A- Agonist/Antagonist protocol

Intervention Type OTHER

In vitro fertilization (IVF/ICSI)

ARM B- Antagonist protocol

Intervention Type OTHER

In vitro fertilization (IVF/ICSI)

ARM B- Antagonist protocol

The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH

Group Type ACTIVE_COMPARATOR

ARM A- Agonist/Antagonist protocol

Intervention Type OTHER

In vitro fertilization (IVF/ICSI)

ARM B- Antagonist protocol

Intervention Type OTHER

In vitro fertilization (IVF/ICSI)

Interventions

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ARM A- Agonist/Antagonist protocol

In vitro fertilization (IVF/ICSI)

Intervention Type OTHER

ARM B- Antagonist protocol

In vitro fertilization (IVF/ICSI)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Up to three previous IVF attempts

Exclusion Criteria

* Patients with poor or no response in previous COH for IVF cycles
* Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
* Risk factor for Diminished Ovarian Reserve
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raoul Orvieto, MD

Role: PRINCIPAL_INVESTIGATOR

Infertility & IVF Unit, Dept. Obstetrics & Gynecology - Director

Locations

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Sheba Medical Center- IVF unit

Ramat Gan, Israel, Israel

Site Status

Countries

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Israel

References

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Orvieto R, Nahum R, Rabinson J, Gemer O, Anteby EY, Meltcer S. Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality. Fertil Steril. 2009 Apr;91(4 Suppl):1398-400. doi: 10.1016/j.fertnstert.2008.04.064. Epub 2008 Aug 3.

Reference Type BACKGROUND
PMID: 18675974 (View on PubMed)

Orvieto R. The ultrashort flare GnRH-agonist/GnRH-antagonist protocol enables cycle programming and may overcome the "detrimental effect" of the oral contraceptive. Fertil Steril. 2012 Sep;98(3):e17-8; author reply e19. doi: 10.1016/j.fertnstert.2012.06.053. Epub 2012 Jul 26. No abstract available.

Reference Type BACKGROUND
PMID: 22840381 (View on PubMed)

Orvieto R, Nahum R, Zohav E, Liberty G, Anteby EY, Meltcer S. GnRH-agonist ovulation trigger in patients undergoing controlled ovarian hyperstimulation for IVF with ultrashort flare GnRH-agonist combined with multidose GnRH-antagonist protocol. Gynecol Endocrinol. 2013 Jan;29(1):51-3. doi: 10.3109/09513590.2012.705376. Epub 2012 Aug 3.

Reference Type BACKGROUND
PMID: 22857268 (View on PubMed)

Orvieto R, Meltcer S, Liberty G, Rabinson J, Anteby EY, Nahum R. A combined approach to patients with repeated IVF failures. Fertil Steril. 2010 Nov;94(6):2462-4. doi: 10.1016/j.fertnstert.2010.03.057. Epub 2010 May 7.

Reference Type BACKGROUND
PMID: 20451192 (View on PubMed)

Orvieto R, Kruchkovich J, Rabinson J, Zohav E, Anteby EY, Meltcer S. Ultrashort gonadotropin-releasing hormone agonist combined with flexible multidose gonadotropin-releasing hormone antagonist for poor responders in in vitro fertilization/embryo transfer programs. Fertil Steril. 2008 Jul;90(1):228-30. doi: 10.1016/j.fertnstert.2007.06.022. Epub 2007 Aug 6.

Reference Type BACKGROUND
PMID: 17681292 (View on PubMed)

Other Identifiers

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SHEBA-14-1078-RO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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