NCT01530490

Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hospital de Cruces · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Complications Associated With Artificial Fertilization
• Disorder of Endocrine Ovary

Interventions

Type	Name	Description
DRUG	Cabergoline and Hydroxyethyl Starch	0.5mg
DRUG	Hydroxyethyl Starch	0.5 mg cabergoline administration 8 days

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-08-01
• Completion: 2010-09-01
• First posted: 2012-02-10
• Last updated: 2012-02-10