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GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268761
First Posted: December 31, 2010
Last Update Posted: September 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan Giles, Instituto Valenciano de Infertilidad, Spain
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Juan Giles, Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 23, 2010
First Posted: December 31, 2010
Last Update Posted: September 19, 2013
Last Verified: September 2013

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

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