Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Matorras, Hospital de Cruces
ClinicalTrials.gov Identifier:
NCT01530490
First received: January 26, 2012
Last updated: February 9, 2012
Last verified: February 2012

January 26, 2012
February 9, 2012
August 2007
August 2008   (final data collection date for primary outcome measure)
risk of ovarian hyperstimulation syndrome [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01530490 on ClinicalTrials.gov Archive Site
pregnancy rate [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Complications Associated With Artificial Fertilization
  • Disorder of Endocrine Ovary
  • Drug: Cabergoline and Hydroxyethyl Starch
    0.5mg
    Other Name: Dostinex
  • Drug: Hydroxyethyl Starch
    0.5 mg cabergoline administration 8 days
    Other Name: Hemoes
  • No Intervention: Hemoes
  • Experimental: Cabergoline
    cabergoline
    Interventions:
    • Drug: Cabergoline and Hydroxyethyl Starch
    • Drug: Hydroxyethyl Starch
Matorras R, Andrés M, Mendoza R, Prieto B, Pijoan JI, Expósito A. Prevention of ovarian hyperstimulation syndrome in GnRH agonist IVF cycles in moderate risk patients: randomized study comparing hydroxyethyl starch versus cabergoline and hydroxyethyl starch. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):439-43. doi: 10.1016/j.ejogrb.2013.07.010. Epub 2013 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2010
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • age > 40 years
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01530490
CEIC0754
Yes
Roberto Matorras, Hospital de Cruces
Hospital de Cruces
Not Provided
Principal Investigator: Roberto Matorras, MD, PhD Hospital Cruces
Hospital de Cruces
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP