Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Early Phase 1

Completed

• Conditions: Complications Associated With Artificial Fertilization; Disorder of Endocrine Ovary
• Interventions: Drug: Cabergoline and Hydroxyethyl Starch; Drug: Hydroxyethyl Starch

• Registration Number: NCT01530490
• Lead Sponsor: Hospital de Cruces

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.

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 Timeline

• Study Start: 2007-08
• Primary Completion: 2008-08
• Study Completion: 2010-09
• Study First Submitted: 2012-01-26
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-09
• Last Update Submitted: 2012-02-09
• Study First Posted: 2012-02-10
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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Exclusion Criteria

• age > 40 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabergoline	Cabergoline and Hydroxyethyl Starch	cabergoline
Cabergoline	Hydroxyethyl Starch	cabergoline

Primary Outcome Measures

Name	Time	Method
risk of ovarian hyperstimulation syndrome	12 days

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	15 days