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| ID | Type | Description | Link |
|---|---|---|---|
| NMRC/NIG/1029/2010 | Other Grant/Funding Number | National Medical Research Council |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabergoline | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline | Drug | Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The development of moderate or severe OHSS necessitating admission for management of OHSS. | Within 2 weeks after hCG trigger |
| Measure | Description | Time Frame |
|---|---|---|
| The need for abdominal or pleural tap | Within 3 weeks after hCG trigger | |
| Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma) | Within 3 weeks after hCG trigger |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Sybille Hendricks, MBBS, MRCOG | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33851429 | Derived | Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4. |
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| Placebo | Drug | 1 tablet daily for 8 days. |
|
| Admission into intensive care | Within 3 weeks after hCG trigger |
| Examination of potential biomarkers for OHSS | 1-2 years |
| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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