Ovarian Hyperstimulation Syndrome and Cabergoline

NCT01569256 | Completed DMC

• 1 other identifier: ESG1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Polycystic Ovarian Syndrome; Ovarian Hyperstimulation Syndrome

Outcome Measures

Primary Outcomes (1)

• Concentrations of follicular fluid AMH

  1 year

Secondary Outcomes (2)

• Concentrations of follicular fluid inhibin B

  1 year

• Concentrations of follicular fluid HGF

  1 year

Study Arms (2)

Cabergoline administered group

ACTIVE COMPARATOR

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

Control arm

NO INTERVENTION

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.

Interventions

Cabergoline DRUG

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

Also known as: Dostinex

Cabergoline administered group

Eligibility Criteria

• Age: 23 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Etlik Zubeyde Hanim Womens' Health and Teaching Hospital: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Emine Seda Guvendag Guven, MD

  Rize University, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 4, 2012

Record last verified: 2012-04