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

Information source: KK Women's and Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Hyperstimulation Syndrome

Intervention: Cabergoline (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: KK Women's and Children's Hospital

Official(s) and/or principal investigator(s):
Marianne Sybille Hendricks, MBBS, MRCOG, Principal Investigator, Affiliation: KK Women's and Children's Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: The development of moderate or severe OHSS necessitating admission for management of OHSS.

Secondary outcome:

The need for abdominal or pleural tap

Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma)

Admission into intensive care

Examination of potential biomarkers for OHSS

Detailed 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.

Eligibility

Minimum age: 21 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

KK Women's and Children's Hospital, Singapore 229899, Singapore
Additional Information

Starting date: April 2012
Last updated: May 8, 2014

Page last updated: August 23, 2015

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