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Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

This study has been completed.
Information provided by (Responsible Party):
Roberto Matorras, Hospital de Cruces Identifier:
First received: January 26, 2012
Last updated: February 9, 2012
Last verified: February 2012
The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

Condition Intervention Phase
Complications Associated With Artificial Fertilization Disorder of Endocrine Ovary Drug: Cabergoline and Hydroxyethyl Starch Drug: Hydroxyethyl Starch Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch

Resource links provided by NLM:

Further study details as provided by Roberto Matorras, Hospital de Cruces:

Primary Outcome Measures:
  • risk of ovarian hyperstimulation syndrome [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 15 days ]

Enrollment: 80
Study Start Date: August 2007
Study Completion Date: September 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Hemoes
Experimental: Cabergoline
Drug: Cabergoline and Hydroxyethyl Starch
Other Name: Dostinex
Drug: Hydroxyethyl Starch
0.5 mg cabergoline administration 8 days
Other Name: Hemoes

Detailed Description:

Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • to be at risk of OHSS were invited to participate in the study

Exclusion Criteria:

  • age > 40 years
  Contacts and Locations
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Please refer to this study by its identifier: NCT01530490

Sponsors and Collaborators
Hospital de Cruces
Principal Investigator: Roberto Matorras, MD, PhD Hospital Cruces
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Roberto Matorras, Head of reproduction Unit, Hospital de Cruces Identifier: NCT01530490     History of Changes
Other Study ID Numbers: CEIC0754
Study First Received: January 26, 2012
Last Updated: February 9, 2012

Keywords provided by Roberto Matorras, Hospital de Cruces:
ovarian hyperstimulation syndrome
hydroxyethyl starch

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hydroxyethyl Starch Derivatives
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes processed this record on August 18, 2017