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GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

Primary Purpose

Ovarian Hyperstimulation Syndrome, Effects of Gonadotropin, Oocyte Maturation

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
GnRH antagonist (Cetrorelix)
Placebo (saline solution)
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring Ovarian hyperstimulation syndrome (OHSS), GnRH antagonist, Ascitis.

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GnRH antagonist

Placebo (saline solution)

Arm Description

• GnRH antagonist (Cetrorelix 0.25)

• Placebo (saline solution)

Outcomes

Primary Outcome Measures

Ultrasound
Ultrasound measurements: ascitis and ovarian size
Blood measurements
Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.

Secondary Outcome Measures

Full Information

First Posted
December 23, 2010
Last Updated
September 18, 2013
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT01268761
Brief Title
GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome
Official Title
Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome, Effects of Gonadotropin, Oocyte Maturation
Keywords
Ovarian hyperstimulation syndrome (OHSS), GnRH antagonist, Ascitis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GnRH antagonist
Arm Type
Experimental
Arm Description
• GnRH antagonist (Cetrorelix 0.25)
Arm Title
Placebo (saline solution)
Arm Type
Placebo Comparator
Arm Description
• Placebo (saline solution)
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist (Cetrorelix)
Intervention Description
•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval
Intervention Type
Drug
Intervention Name(s)
Placebo (saline solution)
Intervention Description
• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval
Primary Outcome Measure Information:
Title
Ultrasound
Description
Ultrasound measurements: ascitis and ovarian size
Time Frame
one week
Title
Blood measurements
Description
Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.
Time Frame
one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Giles, MD
Organizational Affiliation
IVI Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

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GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

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