Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
NCT ID: NCT02875587
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2016-10-31
2018-12-31
Brief Summary
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Detailed Description
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Previous studies revealed that calcium gluconate infusion 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 this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Cabergoline group
Cabergoline is administered starting on the day of HCG administration.
Cabergoline
Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration
Calcium gluconate infusion group
Calcium gluconate is administered starting on the day of HCG administration.
Calcium gluconate
Intravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.
Interventions
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Cabergoline
Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration
Calcium gluconate
Intravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Swelling or inflammation around the heart or lung
* Hypertension
* Liver disease
* Heart valve disease and allergy to cabergoline or ergot derivatives.
18 Years
37 Years
FEMALE
No
Sponsors
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Aljazeera Hospital
OTHER
Responsible Party
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Prof .Usama M.Fouda
M.D, PhD
Principal Investigators
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Usama M Fouda, M.D,PhD
Role: STUDY_CHAIR
Aljazeera( Al Gazeera) hospital
Locations
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Aljazeera hospital
Giza, , Egypt
Riyadh Fertility and Reproductive Health center
Giza, , Egypt
Countries
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References
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Gurgan T, Demirol A, Guven S, Benkhalifa M, Girgin B, Li TC. Intravenous calcium infusion as a novel preventive therapy of ovarian hyperstimulation syndrome for patients with polycystic ovarian syndrome. Fertil Steril. 2011 Jul;96(1):53-7. doi: 10.1016/j.fertnstert.2011.04.094. Epub 2011 May 31.
Other Identifiers
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Cabergoline/calcium gluconate
Identifier Type: -
Identifier Source: org_study_id