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Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

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.
 
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

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 25, 2014
Last Update Posted Date June 25, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Ongoing pregnancy rates [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • Total gonadotropin use [ Time Frame: 2 Years ]
  • Biochemical pregnancy [ Time Frame: 2 Years ]
    Positive pregnancy test without documentation of intrauterine or extrauterine pregnancy
  • Clinical pregnancy [ Time Frame: 2 Years ]
    Positive pregnancy test with documentation of intrauterine or extrauterine pregnancy
  • Multiple pregnancy rate [ Time Frame: 2 Years ]
  • Miscarriage rate [ Time Frame: 2 Years ]
  • Fertilization rate [ Time Frame: 2 Years ]
  • Number of oocytes [ Time Frame: 2 years ]
  • OHSS rates [ Time Frame: 2 Years ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2014)
Positive Pregnancy Test [ Time Frame: 2 Years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF
Official Title  ICMJE Ultrashort Flare GnRH Agonist Combined With Flexible Multidose GnRH Antagonist Versus Flexible Multidose GnRH Antagonist for Good-prognosis IVF Patients
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Other: ARM A- Agonist/Antagonist protocol
    In vitro fertilization (IVF/ICSI)
  • Other: ARM B- Antagonist protocol
    In vitro fertilization (IVF/ICSI)
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: ARM A- Agonist/Antagonist protocol
    • Other: ARM B- Antagonist protocol
  • Active Comparator: ARM B- Antagonist protocol
    The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH
    Interventions:
    • Other: ARM A- Agonist/Antagonist protocol
    • Other: ARM B- Antagonist protocol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 23, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02173977
Other Study ID Numbers  ICMJE SHEBA-14-1078-RO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sheba Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheba Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raoul Orvieto, MD Infertility & IVF Unit, Dept. Obstetrics & Gynecology - Director
PRS Account Sheba Medical Center
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP