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Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

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.
ClinicalTrials.gov Identifier: NCT01530490
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Complications Associated With Artificial Fertilization Disorder of Endocrine Ovary Drug: Cabergoline and Hydroxyethyl Starch Drug: Hydroxyethyl Starch Early Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : August 2007
Primary Completion Date : August 2008
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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): NCT01530490


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberto Matorras, Head of reproduction Unit, Hospital de Cruces
ClinicalTrials.gov Identifier: NCT01530490     History of Changes
Other Study ID Numbers: CEIC0754
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Roberto Matorras, 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
Cabergoline
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