Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome
Overview
- Phase
- Phase 3
- Intervention
- GnRH antagonist (Cetrorelix)
- Conditions
- Ovarian Hyperstimulation Syndrome
- Sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Ultrasound
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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).
Investigators
Juan Giles
Principal Investigator; Gynecologist IVI Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA
Eligibility Criteria
Inclusion Criteria
- •Egg donors
- •Volunteers.
- •18-35 years old
- •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
Arms & Interventions
GnRH antagonist
• GnRH antagonist (Cetrorelix 0.25)
Intervention: GnRH antagonist (Cetrorelix)
Placebo (saline solution)
• Placebo (saline solution)
Intervention: Placebo (saline solution)
Outcomes
Primary Outcomes
Ultrasound
Time Frame: one week
Ultrasound measurements: ascitis and ovarian size
Blood measurements
Time Frame: one week
Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.