Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

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.

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Key information

Conditions

Complications Associated With Artificial Fertilization Adnexal Diseases Disorder of Endocrine Ovary Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Ovarian Hyperstimulation Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

age > 40 years

Treatment and study plan

Cabergoline and Hydroxyethyl Starch

Drug

0.5mg

Other names: Dostinex

Hydroxyethyl starch

Drug

0.5 mg cabergoline administration 8 days

Other names: Hemoes

Primary outcomes

risk of ovarian hyperstimulation syndrome

Time frame: 12 days

Secondary outcomes

pregnancy rate

Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Hospital de Cruces

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2010
First posted: Feb 10, 2012
Registry last updated: Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed