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

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535859
• Other study ID #: KNMRCNIG1031
• Secondary ID: NMRC/NIG/1029/20
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2018
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

Drug:
• Cabergoline
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
• Placebo
1 tablet daily for 8 days.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The development of moderate or severe OHSS necessitating admission for management of OHSS.		Within 2 weeks after hCG trigger
Secondary	The need for abdominal or pleural tap		Within 3 weeks after hCG trigger
Secondary	Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma)		Within 3 weeks after hCG trigger
Secondary	Admission into intensive care		Within 3 weeks after hCG trigger
Secondary	Examination of potential biomarkers for OHSS		1-2 years