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Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

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ClinicalTrials.gov Identifier: NCT02173977
Recruitment Status : Unknown
Verified June 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infertility Other: ARM A- Agonist/Antagonist protocol Other: ARM B- Antagonist protocol Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrashort Flare GnRH Agonist Combined With Flexible Multidose GnRH Antagonist Versus Flexible Multidose GnRH Antagonist for Good-prognosis IVF Patients
Study Start Date : June 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Other: ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)

Other: ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)
Active Comparator: ARM B- Antagonist protocol
The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH
 Other: ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)

Other: ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)


Outcome Measures
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Primary Outcome Measures :
  1. Ongoing pregnancy rates [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Total gonadotropin use [ Time Frame: 2 Years ]
  2. Biochemical pregnancy [ Time Frame: 2 Years ]
    Positive pregnancy test without documentation of intrauterine or extrauterine pregnancy

  3. Clinical pregnancy [ Time Frame: 2 Years ]
    Positive pregnancy test with documentation of intrauterine or extrauterine pregnancy

  4. Multiple pregnancy rate [ Time Frame: 2 Years ]
  5. Miscarriage rate [ Time Frame: 2 Years ]
  6. Fertilization rate [ Time Frame: 2 Years ]
  7. Number of oocytes [ Time Frame: 2 years ]
  8. OHSS rates [ Time Frame: 2 Years ]
  9. Embryo quality [ Time Frame: 2 Years ]

    Grading of a day 3 embryo based on the number of cells that make up the embryo, the amount of fragmentation, and the symmetry of each of the embryo's cells (blastomeres).

    E.g. good quality embryos: embryos that reach the eight-cell stage with less than 20% fragmentation on day 3



Other Outcome Measures:
  1. Positive Pregnancy Test [ Time Frame: 2 Years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02173977


Locations
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Israel
Sheba Medical Center- IVF unit
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Raoul Orvieto, MD Infertility & IVF Unit, Dept. Obstetrics & Gynecology - Director
More Information
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Publications:

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02173977    
Other Study ID Numbers: SHEBA-14-1078-RO-CTIL
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by Sheba Medical Center:
GnRH Agonist
GnRH Antagonist
OHSS
Additional relevant MeSH terms:
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Infertility