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GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

This study is currently recruiting participants.
Verified March 2012 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01268761
First received: December 23, 2010
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Ovarian Hyperstimulation Syndrome
Effects of Gonadotropin
Oocyte Maturation
 Drug: GnRH antagonist (Cetrorelix)
Drug: Placebo (saline solution)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Ultrasound [ Time Frame: one week ] [ Designated as safety issue: No ]
    Ultrasound measurements: ascitis and ovarian size

  • Blood measurements [ Time Frame: one week ] [ Designated as safety issue: No ]
    Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.


Estimated Enrollment: 62
Study Start Date: December 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GnRH antagonist
• GnRH antagonist (Cetrorelix 0.25)
 Drug: GnRH antagonist (Cetrorelix)
•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval
Placebo Comparator: Placebo (saline solution)
• Placebo (saline solution)
 Drug: Placebo (saline solution)
• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval

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).

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268761

Contacts
Contact: Leslie Atkinson, MA 34963050900 leslie.atkinson@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Juan Giles, MD     34 963050900     juan.giles@ivi.es    
Contact: Leslie Atkinson, MA     34 963050900     leslie.atkinson@ivi.es    
Principal Investigator: Juan Giles, MD            
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Juan Giles, MD IVI Valencia
  More Information

No publications provided

Responsible Party: Dr. Juan Giles, IVI Valencia
ClinicalTrials.gov Identifier: NCT01268761     History of Changes
Other Study ID Numbers: 0810-C-052-JG
Study First Received: December 23, 2010
Last Updated: March 30, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Ovarian hyperstimulation syndrome (OHSS)
GnRH antagonist
Ascitis.

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
 Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013