GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

Phase 3

Completed

• Conditions: Ovarian Hyperstimulation Syndrome; Effects of Gonadotropin; Oocyte Maturation
• Interventions: Drug: GnRH antagonist (Cetrorelix); Drug: Placebo (saline solution)

• Registration Number: NCT01268761
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-30
• Study First Posted: 2010-12-31
• Study Start: 2012-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH antagonist	GnRH antagonist (Cetrorelix)	• GnRH antagonist (Cetrorelix 0.25)
Placebo (saline solution)	Placebo (saline solution)	• Placebo (saline solution)

Primary Outcome Measures

Name	Time	Method
Ultrasound	one week	Ultrasound measurements: ascitis and ovarian size
Blood measurements	one week	Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain