GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

Study Overview
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Brief Summary
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The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.

Detailed Description
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Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).

Official Title
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Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome

Conditions
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Ovarian Hyperstimulation Syndrome, Effects of Gonadotropin, Oocyte Maturation

Intervention / Treatment
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* Drug: GnRH antagonist (Cetrorelix)
* Drug: Placebo (saline solution)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Egg donors Volunteers. 18-35 years old Healthy BMI < 30 OHHS after oocyte retrieval defined as ascitis > 9 cm2 associate to abdominal pain, sickness, abdominal distention,or haematocrit (Ht) >45% an white blood cell count >15,000/mm3 or creatine > 1.2 mg/dl or transaminases > 40 IU/liter Exclusion Criteria: BMI > 30 Allergy to GnRH antagonist

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH antagonist<br>• GnRH antagonist (Cetrorelix 0.25) | Drug: GnRH antagonist (Cetrorelix)<br>* •GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval<br>|
| Placebo Comparator: Placebo (saline solution)<br>• Placebo (saline solution) | Drug: Placebo (saline solution)<br>* • Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound | Ultrasound measurements: ascitis and ovarian size | one week | 
| Blood measurements | Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian hyperstimulation syndrome (OHSS), GnRH antagonist, Ascitis.