Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

Study Overview
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Brief Summary
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To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

Detailed Description
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The combined ultrashort flare GnRH agonist /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 is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist. A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met. The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to better programme an antagonist cycle and improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.

Official Title
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Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
* Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with poor or no response in previous COH for IVF cycles Patients with AMH < 1 and/or FSH >12 Poor quality of embryos in previous cycles Age of patients up to 44 years Exclusion Criteria: Patients with normal ovarian reserve Patients with sonographically detected hydrosalpinges Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome Women with thrombofilia disorders

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Oestradiol and ultrashort GnRH agonist/antagonist protocol<br>Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol | Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol<br> <br> |
| Active Comparator: GnRH agonist or antagonist protocol.<br>Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF | Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 2 years | 
| Clinical pregnancy rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 2 years | 
| Top embryo quality at day 2 |  | 2 years | 
| Biochemical pregnancy |  | 2 years | 
| Ectopic pregnancy |  | 2 years | 
| Miscarriage rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol