Cabergoline Reduces OHSS

This study has been completed.

First Received: February 23, 2007 Last Updated: February 26, 2007 History of Changes

Sponsor:	Instituto Valenciano de Infertilidad, Spain
Information provided by:	Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:	NCT00440258

Purpose

The present study was designed to provide clinical confirmation of Cb2’s value as a new approach in the prevention of increased vascular permeability and hemoconcentration, both signs of OHSS in humans, and in order to explore its mechanism of action. To this end, a prospective, randomized, placebo-controlled study was designed in which Cb2 was employed in women at risk of OHSS after gonadotropin administration for ART. Simultaneously, ovarian perfusion was assessed in these patients using MR pharmacokinetic modeling.

Condition	Intervention	Phase
Ovarian Hyperstimulation Syndrome	Drug: Cabergoline Procedure: MR Procedure: Ultrasound Procedure: Blood Analysis	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Dopamine Agonist Cabergoline Reduces Hemoconcentration and Ascites in Hyperstimulated Women Undergoing Assisted Reproduction.

Resource links provided by NLM:

Drug Information available for: Dopamine Dopamine hydrochloride Cabergoline Cabergoline diphosphate

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Estimated Enrollment:	60
Study Start Date:	April 2004
Estimated Study Completion Date:	July 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 - 35 years old healthy women, with risk of developing OHSS.

Exclusion Criteria:

No risk of developing OHSS; < 20 oocytes retrieved.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440258

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, Spain

Investigators

Study Director:

Antonio Pellicer, MD

IVI VALENCIA

More Information

No publications provided

Study ID Numbers:	VLC-AP-404-207-1
Study First Received:	February 23, 2007
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00440258 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, Spain:

Ovarian hyperstimulation syndrome, dopamine agonists, cabergoline, hemoconcentration, ascites, ovarian perfusion, dopamine receptor 2

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Antiparkinson Agents
Endocrine System Diseases
Ovarian Diseases
Dopamine Agonists

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Pathologic Processes
Syndrome
Ovarian Hyperstimulation Syndrome
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Cabergoline

ClinicalTrials.gov processed this record on November 09, 2009