Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Cruces University Hospital

Status and phase: Completed; Early Phase 1

Conditions: Complications Associated With Artificial Fertilization; Disorder of Endocrine Ovary

Treatments: Drug: Hydroxyethyl Starch; Drug: Cabergoline and Hydroxyethyl Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT01530490

CEIC0754

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• age > 40 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Hemoes

No Intervention group

Cabergoline

Experimental group

Description:

cabergoline

Treatment:

Drug: Cabergoline and Hydroxyethyl Starch

Drug: Hydroxyethyl Starch