Back to resultsOvarian Hyperstimulation Syndrome and Cabergoline
Primary Purpose
Polycystic Ovarian Syndrome, Ovarian Hyperstimulation Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cabergoline
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovarian Syndrome
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cabergoline administered group
Control arm
Arm 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.
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.
Outcomes
Primary Outcome Measures
Concentrations of follicular fluid AMH
Secondary Outcome Measures
Concentrations of follicular fluid inhibin B
Concentrations of follicular fluid HGF
Full Information
NCT ID
NCT01569256
First Posted
March 26, 2012
Last Updated
April 3, 2012
Sponsor
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01569256
Brief Title
Ovarian Hyperstimulation Syndrome and Cabergoline
Official Title
The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Ovarian Hyperstimulation Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabergoline administered group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control arm
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
Dostinex
Intervention Description
Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days
Primary Outcome Measure Information:
Title
Concentrations of follicular fluid AMH
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Concentrations of follicular fluid inhibin B
Time Frame
1 year
Title
Concentrations of follicular fluid HGF
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Seda Guvendag Guven, MD
Organizational Affiliation
Rize University, Faculty of Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Ovarian Hyperstimulation Syndrome and Cabergoline
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