GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

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.

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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

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