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The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.
Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of assisted reproduction. Complications of OHSS include vascular thrombosis, pulmonary embolism, renal failure, electrolyte disturbances, ascites, hydrothorax ,torsion of the ovary, abortion or rarely death.
Previous studies revealed that converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.
The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabergoline group | Active Comparator | Cabergoline is administered starting on the day of HCG administration. |
|
| GnRH antagonist rescue & cabergoline group | Experimental | Converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) and Cabergoline is administered starting on the day of HCG administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline | Drug | Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Moderate or severe ovarian hyperstimulation syndrome | Within 4 weeks of HCG adminstration |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Achieved Ongoing Pregnancy | 18 weeks after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Usama M Fouda, M.D,PhD | Contact | 01095401375 | umfrfouda@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Usama M Fouda, M.D,PhD | Aljazeera (Al Gazeera) hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aljazeera( Al Gazeera) hospital | Recruiting | Giza | Giza Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17854523 | Background | Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9. doi: 10.1016/s1472-6483(10)60339-2. | |
| 27184139 | Derived | Fouda UM, Sayed AM, Elshaer HS, Hammad BE, Shaban MM, Elsetohy KA, Youssef MA. GnRH antagonist rescue protocol combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome: a randomized controlled trial. J Ovarian Res. 2016 May 17;9(1):29. doi: 10.1186/s13048-016-0237-8. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| GnRH antagonist rescue & cabergoline | Drug | when the leading follicle reaches 16 mm, HP-uFSH is continued at daily dose of 75 IU/day till the day of HCG administration. Moreover, Gn RH agonist (triptorelin) is discontinued and GnRH antagonist (Cetrorelix acetate)0.25 mg S.C is administered daily till the day of HCG administration. Serum estradiol is measured daily and HCG (5,000 IU/I.M) is administered when serum estradiol level drops below 3500 pg/ml . Moreover, cabergoline 0.5 mg p.o is administered at bed time for 8 days starting on the day of HCG administration. |
|
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |