Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

Study Overview
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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.

Official Title
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Ultrashort Flare GnRH Agonist Combined With Flexible Multidose GnRH Antagonist Versus Flexible Multidose GnRH Antagonist for Good-prognosis IVF Patients

Conditions
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Infertility

Intervention / Treatment
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* Other: ARM A- Agonist/Antagonist protocol
* Other: ARM B- Antagonist protocol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM A- Agonist/Antagonist protocol<br>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<br>* In vitro fertilization (IVF/ICSI)<br>Other: ARM B- Antagonist protocol<br>* In vitro fertilization (IVF/ICSI)<br>|
| Active Comparator: ARM B- Antagonist protocol<br>The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH | Other: ARM A- Agonist/Antagonist protocol<br>* In vitro fertilization (IVF/ICSI)<br>Other: ARM B- Antagonist protocol<br>* In vitro fertilization (IVF/ICSI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rates |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total gonadotropin use |  | 2 Years | 
| Biochemical pregnancy | Positive pregnancy test without documentation of intrauterine or extrauterine pregnancy | 2 Years | 
| Clinical pregnancy | Positive pregnancy test with documentation of intrauterine or extrauterine pregnancy | 2 Years | 
| Multiple pregnancy rate |  | 2 Years | 
| Miscarriage rate |  | 2 Years | 
| Fertilization rate |  | 2 Years | 
| Number of oocytes |  | 2 years | 
| OHSS rates |  | 2 Years | 
| Embryo quality | 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 | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH Agonist, GnRH Antagonist, OHSS