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Cabergoline Reduces OHSS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440258
First Posted: February 26, 2007
Last Update Posted: February 27, 2007
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.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  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 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

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

  Eligibility

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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Study Director: Antonio Pellicer, MD IVI VALENCIA
  More Information

ClinicalTrials.gov Identifier: NCT00440258     History of Changes
Other Study ID Numbers: VLC-AP-404-207-1
First Submitted: February 23, 2007
First Posted: February 26, 2007
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
Cabergoline
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
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