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The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Diosmin group) | Active Comparator | In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days. |
|
| Group B(Cabergoline group) | Active Comparator | while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be given at day of HCG injection and for 8 days . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmin | Drug | 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ovarian hyperstimulation syndrome (OHSS) | Diagnosis of OHSS was made according to the criteria of Golan et al.. Mild OHSS was classified as: Grade 1 (abdominal distension and discomfort) and Grade 2 (features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm), moderate OHSS as Grade 3 (features of mild OHSS plus ultrasonic evidence of ascites), severe OHSS as Grade 4 (features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties) and Grade 5 (all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function). | every week for eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | β-hCG (serum hCG test) will be checked 14 days after embryos transfer | 14 days after embryos transfer |
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Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) with one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| khalid mohamed, MD | Department of Obstetrics and Gynecology, Benha University Hospital | Principal Investigator |
| ahmed samy, MD | Department of Obstetrics and Gynecology, Benha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banha Universty | Banhā | El Qalubia | 13518 | Egypt | ||
| Benha univesity hospital |
| 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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with other researcher on research gate
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Cabergoline | Drug | 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days |
|
|
| Banhā |
| El Qualyobia |
| 13518 |
| Egypt |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |