Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
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ClinicalTrials.gov Identifier: NCT01530490 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
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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 |
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 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 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | September 2010 |

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 |
- risk of ovarian hyperstimulation syndrome [ Time Frame: 12 days ]
- pregnancy rate [ Time Frame: 15 days ]

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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

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
Principal Investigator: | Roberto Matorras, MD, PhD | Hospital Cruces |
Responsible Party: | Roberto Matorras, Head of reproduction Unit, Hospital de Cruces |
ClinicalTrials.gov Identifier: | NCT01530490 |
Other Study ID Numbers: |
CEIC0754 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | February 10, 2012 |
Last Verified: | February 2012 |
IVF ovarian hyperstimulation syndrome cabergoline hydroxyethyl starch prevention |
Ovarian Hyperstimulation Syndrome Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Cabergoline Hydroxyethyl Starch Derivatives Antiparkinson Agents |
Anti-Dyskinesia Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Plasma Substitutes Blood Substitutes |