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GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

NCT ID: NCT01268761

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Ovarian Hyperstimulation Syndrome Effects of Gonadotropin Oocyte Maturation

Keywords

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Ovarian hyperstimulation syndrome (OHSS) GnRH antagonist Ascitis.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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GnRH antagonist

• GnRH antagonist (Cetrorelix 0.25)

Group Type EXPERIMENTAL

GnRH antagonist (Cetrorelix)

Intervention Type DRUG

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

Placebo (saline solution)

• Placebo (saline solution)

Group Type PLACEBO_COMPARATOR

Placebo (saline solution)

Intervention Type DRUG

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

Interventions

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GnRH antagonist (Cetrorelix)

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

Intervention Type DRUG

Placebo (saline solution)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Juan Giles

Principal Investigator; Gynecologist IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Giles, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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IVI Valencia

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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0810-C-052-JG

Identifier Type: -

Identifier Source: org_study_id