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Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers

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ClinicalTrials.gov Identifier: NCT01535859
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

February 15, 2012
February 20, 2012
August 7, 2018
April 2012
June 2015   (Final data collection date for primary outcome measure)
The development of moderate or severe OHSS necessitating admission for management of OHSS. [ Time Frame: Within 2 weeks after hCG trigger ]
Same as current
Complete list of historical versions of study NCT01535859 on ClinicalTrials.gov Archive Site
  • The need for abdominal or pleural tap [ Time Frame: Within 3 weeks after hCG trigger ]
  • Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma) [ Time Frame: Within 3 weeks after hCG trigger ]
  • Admission into intensive care [ Time Frame: Within 3 weeks after hCG trigger ]
  • Examination of potential biomarkers for OHSS [ Time Frame: 1-2 years ]
Same as current
Not Provided
Not Provided
 
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.
The purpose of this study is to determine whether cabergoline is effective in reducing the incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe cases; and to derive biomarkers for the risk of developing OHSS.

Severe ovarian hyperstimulation syndrome (OHSS) occurs in up to 2% of in-vitro fertilisation (IVF) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced perfusion of vital organs, renal failure, acute respiratory failure, and even death.

The long term aim is to develop a comprehensive strategy in reducing the incidence and severity of OHSS in in-vitro fertilisation (IVF) cycles. Our short term aim (2-3 years) is to test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and severity of OHSS in high risk women undergoing controlled ovarian hyperstimulation (COH) in fresh IVF cycles through a reduction in vasoactive cytokine levels, specifically in serum vascular-endothelial growth factor (VEGF).

Specifically we will:

  1. Conduct a randomised double-blind placebo-controlled trial in women at high risk of developing OHSS during a fresh COH-IVF cycle
  2. Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Ovarian Hyperstimulation Syndrome
  • Drug: Cabergoline
    Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
    Other Name: Dostinex
  • Drug: Placebo
    1 tablet daily for 8 days.
  • Experimental: Cabergoline
    Intervention: Drug: Cabergoline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
540
June 2016
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with more than 20 oocytes collected after COH in both gonadotropin-releasing hormone (GnRH) agonist and antagonist cycles

Exclusion Criteria:

  • Patients with allergy to dopamine agonists
  • Patients who undergo in-vitro maturation cycles
  • Patients where GnRH analogues have been used to trigger oocyte maturation in antagonist cycles
Sexes Eligible for Study: Female
21 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01535859
KNMRCNIG1031
NMRC/NIG/1029/2010 ( Other Grant/Funding Number: National Medical Research Council )
Yes
Not Provided
Not Provided
KK Women's and Children's Hospital
KK Women's and Children's Hospital
Not Provided
Principal Investigator: Marianne Sybille Hendricks, MBBS, MRCOG KK Women's and Children's Hospital
KK Women's and Children's Hospital
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP