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Sponsored by: |
Instituto Valenciano de Infertilidad, Spain |
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Information provided by: | Instituto Valenciano de Infertilidad, Spain |
ClinicalTrials.gov Identifier: | NCT00440258 |
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 |
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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. |
Estimated Enrollment: | 60 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | VLC-AP-404-207-1 |
Study First Received: | February 23, 2007 |
Last Updated: | February 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00440258 |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Ovarian hyperstimulation syndrome, dopamine agonists, cabergoline, hemoconcentration, ascites, ovarian perfusion, dopamine receptor 2 |
Genital Diseases, Female Dopamine Gonadal Disorders Ascites Ovarian Hyperstimulation Syndrome |
Endocrine System Diseases Endocrinopathy Ovarian Diseases Cabergoline |
Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Dopamine Agonists |
Pharmacologic Actions Adnexal Diseases Pathologic Processes Syndrome Therapeutic Uses Dopamine Agents Central Nervous System Agents |