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Ovarian Hyperstimulation Syndrome and Cabergoline

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ClinicalTrials.gov Identifier: NCT01569256
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Emine Seda Guvendag Guven, Etlik Zubeyde Hanım Women's Health Care, Training and Research 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).

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Ovarian Hyperstimulation Syndrome Drug: Cabergoline Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cabergoline administered group

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

No Intervention: Control arm

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.




Primary Outcome Measures :
  1. Concentrations of follicular fluid AMH [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Concentrations of follicular fluid inhibin B [ Time Frame: 1 year ]
  2. Concentrations of follicular fluid HGF [ Time Frame: 1 year ]


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Ages Eligible for Study:   23 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569256


Sponsors and Collaborators
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Investigators
Study Chair: Emine Seda Guvendag Guven, MD Rize University, Faculty of Medicine

Responsible Party: Assoc. Prof. Emine Seda Guvendag Guven, Assoc. Prof., Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01569256     History of Changes
Other Study ID Numbers: ESG1
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Cabergoline
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs