Ovarian Hyperstimulation Syndrome and Cabergoline

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Status: Completed

Conditions: Ovarian Hyperstimulation Syndrome; Polycystic Ovarian Syndrome

Treatments: Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT01569256

ESG1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 23 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Cabergoline administered group

Active Comparator group

Description:

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.

Treatment:

Drug: Cabergoline

Control arm

No Intervention group

Description:

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.