Ovarian Hyperstimulation Syndrome and Cabergoline

Not Applicable

Completed

• Conditions: Polycystic Ovarian Syndrome; Ovarian Hyperstimulation Syndrome
• Interventions: Drug: Cabergoline

• Registration Number: NCT01569256
• Lead Sponsor: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Brief Summary

Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).

Detailed Description

Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2012-03-26
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-03
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
• Having the criteria of PCOS

Exclusion Criteria

• Not having the inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabergoline administered group	Cabergoline	The patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS. All patients were administered long luteal protocol for ovulation induction.

Primary Outcome Measures

Name	Time	Method
Concentrations of follicular fluid AMH	1 year

Secondary Outcome Measures

Name	Time	Method
Concentrations of follicular fluid inhibin B	1 year
Concentrations of follicular fluid HGF	1 year