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GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan Giles, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01268761
First received: December 23, 2010
Last updated: September 18, 2013
Last verified: September 2013
  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:


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

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.


Enrollment: 100
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: Juan Giles, MD IVI Valencia
  More Information

No publications provided

Responsible Party: Juan Giles, Principal Investigator; Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01268761     History of Changes
Other Study ID Numbers: 0810-C-052-JG
Study First Received: December 23, 2010
Last Updated: September 18, 2013
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Syndrome
Adnexal Diseases
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Pathologic Processes
Cetrorelix
Pharmaceutical Solutions
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014