Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Complications Associated With Artificial Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530490
• Other study ID #: CEIC0754
• Status: Completed
• Phase: Phase 0
• First received: January 26, 2012
• Last updated: February 9, 2012
• Start date: August 2007
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: Hospital de Cruces
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• age > 40 years

Study Design

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

Related Conditions & MeSH terms

• Complications Associated With Artificial Fertilization
• Disorder of Endocrine Ovary
• Ovarian Diseases
• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• Cabergoline and Hydroxyethyl Starch
0.5mg
• Hydroxyethyl Starch
0.5 mg cabergoline administration 8 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Cruces

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of ovarian hyperstimulation syndrome		12 days	No
Secondary	pregnancy rate		15 days	No