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OpenTrials
Completed

NCT Number: NCT01569256

Ovarian Hyperstimulation Syndrome and Cabergoline

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).

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Key information

Conditions

Polycystic Ovarian Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Ovarian Hyperstimulation Syndrome Polycystic Ovary Syndrome Urogenital Diseases

Age range

23 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cabergoline

Drug

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

Other names: Dostinex

Primary outcomes

  1. Concentrations of follicular fluid AMH

    Time frame: 1 year

Secondary outcomes

  1. Concentrations of follicular fluid inhibin B

    Time frame: 1 year

  2. Concentrations of follicular fluid HGF

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Unknown

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 3, 2012
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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