Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients

Study Overview
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Brief Summary
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The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.

Detailed Description
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Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved. Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles >11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence. Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

Official Title
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Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients Undergoing Ovarian Stimulation for IVF With GnRH Antagonists and Recombinant FSH.

Conditions
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Subfertility

Intervention / Treatment
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* Drug: 0.1 mg triptorelin
* Drug: 0.2 mg triptorelin
* Drug: 0.4 mg triptorelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ovarian stimulation for IVF using GnRH antagonist protocol Age < 40 years Anticipated high ovarian response Exclusion Criteria: Endometriosis > than grade II One ovary

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.2 mg triptorelin<br>0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin | Drug: 0.2 mg triptorelin<br> <br> |
| Active Comparator: 0.1 mg triptorelin<br>0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin | Drug: 0.1 mg triptorelin<br> <br> |
| Active Comparator: 0.4 mg triptorelin<br>0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin | Drug: 0.4 mg triptorelin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of mature oocytes retrieved | Percentage of mature oocytes retrieved following oocyte retrieval | 36 hours post GnRH agonst administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of oocytes retrieved |  | 36 hours post GnRH agonist administration | 
| oocyte recovery rate |  | 36 hours post GnRH agonist administration | 
| Fertilization rate |  | Day 1 post oocyte retrieval | 
| Serum LH, FSH, E2, PRG levels |  | 8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration | 
| Duration of luteal phase |  | 16 days | 
| OHSS occurrence | Occurrence of ovarian hyperstimulation syndrome | 16 days post triggering | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH agonist, OHSS, Triggering final oocyte maturation