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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01530490
Other study ID # CEIC0754
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Terminated NCT02124291 - Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome N/A
Completed NCT01565265 - Comparing Ovarian Stimulation for Assisted Reproduction With Two Different Forms of Pituitary Suppression N/A