Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Early Phase 1CompletedNCT01530490

Hospital de Cruces80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Complications Associated With Artificial Fertilization Disorder of Endocrine Ovary

Interventions

Cabergoline and Hydroxyethyl StarchDRUG

0.5mg

Hydroxyethyl StarchDRUG

0.5 mg cabergoline administration 8 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * to be at risk of OHSS were invited to participate in the study Exclusion Criteria: * age \> 40 years

Outcomes

Primary Outcomes

risk of ovarian hyperstimulation syndrome

Time frame: 12 days

Secondary Outcomes

pregnancy rate

Time frame: 15 days

Data from ClinicalTrials.gov

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