NCT01268761

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

December 23, 2010

Last Update Submit

September 18, 2013

Conditions

Ovarian Hyperstimulation SyndromeEffects of GonadotropinOocyte Maturation

Keywords

Ovarian hyperstimulation syndrome (OHSS)GnRH antagonistAscitis.

Outcome Measures

Primary Outcomes (2)

  • Ultrasound

    Ultrasound measurements: ascitis and ovarian size

    one week

  • Blood measurements

    Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.

    one week

Study Arms (2)

GnRH antagonist

EXPERIMENTAL

• GnRH antagonist (Cetrorelix 0.25)

Drug: GnRH antagonist (Cetrorelix)

Placebo (saline solution)

PLACEBO COMPARATOR

• Placebo (saline solution)

Drug: Placebo (saline solution)

Interventions

GnRH antagonist (Cetrorelix)DRUG

•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval

GnRH antagonist
Placebo (saline solution)DRUG

• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval

Placebo (saline solution)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Egg donors
  • Volunteers.
  • 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

You may not qualify if:

  • BMI \> 30
  • Allergy to GnRH antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

cetrorelixSaline Solution

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Juan Giles, MD

    IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Gynecologist IVI Valencia

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 31, 2010

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

ES(1)