Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF
- Conditions
- Infertility
- Interventions
- Other: ARM A- Agonist/Antagonist protocolOther: ARM B- Antagonist protocol
- Registration Number
- NCT02173977
- Lead Sponsor
- Sheba Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
- Up to three previous IVF attempts
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM A- Agonist/Antagonist protocol 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 ARM A- Agonist/Antagonist protocol ARM B- 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 ARM B- Antagonist protocol ARM A- Agonist/Antagonist protocol The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH ARM B- Antagonist protocol ARM B- Antagonist protocol The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rates 2 years
- Secondary Outcome Measures
Name Time Method Total gonadotropin use 2 Years Biochemical pregnancy 2 Years Positive pregnancy test without documentation of intrauterine or extrauterine pregnancy
Clinical pregnancy 2 Years Positive pregnancy test with documentation of intrauterine or extrauterine pregnancy
Multiple pregnancy rate 2 Years Miscarriage rate 2 Years Fertilization rate 2 Years Number of oocytes 2 years OHSS rates 2 Years Embryo quality 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
Trial Locations
- Locations (1)
Sheba Medical Center- IVF unit
🇮🇱Ramat Gan, Israel