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
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