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Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Matorras, Hospital de Cruces
ClinicalTrials.gov Identifier:
NCT01530490
First received: January 26, 2012
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Hospital de Cruces:

Primary Outcome Measures:
  • risk of ovarian hyperstimulation syndrome [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 15 days ] [ Designated as safety issue: No ]

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
cabergoline
 Drug: Cabergoline and Hydroxyethyl Starch
0.5mg
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Roberto Matorras, Head of reproduction Unit, Hospital de Cruces
ClinicalTrials.gov Identifier: NCT01530490     History of Changes
Other Study ID Numbers: CEIC0754
Study First Received: January 26, 2012
Last Updated: February 9, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital de Cruces:
IVF
ovarian hyperstimulation syndrome
cabergoline
hydroxyethyl starch
prevention

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hetastarch
Cabergoline
Plasma Substitutes
Blood Substitutes
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013