Ovarian Hyperstimulation Syndrome and Cabergoline

Polycystic Ovarian Syndrome Clinical Trial

Official title:

The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569256
• Other study ID #: ESG1
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: April 3, 2012
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2012
• Source: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Cabergoline
Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of follicular fluid AMH		1 year	No
Secondary	Concentrations of follicular fluid inhibin B		1 year	No
Secondary	Concentrations of follicular fluid HGF		1 year	No