Ovarian Hyperstimulation Syndrome and Cabergoline

Study Overview
=================
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.

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

Conditions
-----------------
Polycystic Ovarian Syndrome, Ovarian Hyperstimulation Syndrome

Intervention / Treatment
-----------------
* Drug: Cabergoline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cabergoline administered group<br>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. | Drug: Cabergoline<br>* Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days<br>* Other names: Dostinex;|
| No Intervention: Control arm<br>The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group. All patients were administered long luteal protocol for ovulation induction. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of follicular fluid AMH |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of follicular fluid inhibin B |  | 1 year | 
| Concentrations of follicular fluid HGF |  | 1 year |