Cabergoline Reduces OHSS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440258
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : February 27, 2007
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: Cabergoline Procedure: MR Procedure: Ultrasound Procedure: Blood Analysis Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Dopamine Agonist Cabergoline Reduces Hemoconcentration and Ascites in Hyperstimulated Women Undergoing Assisted Reproduction.
Study Start Date : April 2004
Study Completion Date : July 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • No risk of developing OHSS; < 20 oocytes retrieved.

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Please refer to this study by its identifier (NCT number): NCT00440258

Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study Director: Antonio Pellicer, MD IVI VALENCIA Identifier: NCT00440258     History of Changes
Other Study ID Numbers: VLC-AP-404-207-1
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
Ovarian hyperstimulation syndrome, dopamine agonists, cabergoline, hemoconcentration, ascites, ovarian perfusion, dopamine receptor 2

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dopamine Agonists
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents