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Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Information source: Hospital de Cruces
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complications Associated With Artificial Fertilization; Disorder of Endocrine Ovary

Intervention: Cabergoline and Hydroxyethyl Starch (Drug); Hydroxyethyl Starch (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Hospital de Cruces

Official(s) and/or principal investigator(s):
Roberto Matorras, MD, PhD, Principal Investigator, Affiliation: Hospital Cruces

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: risk of ovarian hyperstimulation syndrome

Secondary outcome: pregnancy rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- age > 40 years

Locations and Contacts

Additional Information

Starting date: August 2007
Last updated: February 9, 2012

Page last updated: August 23, 2015

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