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.
Full Title of Study: “Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: August 2018
Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction. 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.
- Drug: 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
- Drug: 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.
Arms, Groups and Cohorts
- Active Comparator: Cabergoline group
- Cabergoline is administered starting on the day of HCG administration.
- Experimental: Calcium gluconate infusion group
- Calcium gluconate is administered starting on the day of HCG administration.
Clinical Trial Outcome Measures
- Moderate or severe ovarian hyperstimulation syndrome
- Time Frame: Within 4 weeks of HCG adminstration
- The Number of Participants Who Achieved Ongoing Pregnancy
- Time Frame: 18 weeks after embryo transfer
Participating in This Clinical Trial
- Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS [have more than 18 follicles (> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration]. Exclusion Criteria:
- Fibrosis of lung – Swelling or inflammation around the heart or lung – Hypertension – Liver disease – Heart valve disease and allergy to cabergoline or ergot derivatives.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 37 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Aljazeera Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Prof .Usama M.Fouda, M.D, PhD – Aljazeera Hospital
- Overall Official(s)
- Usama M Fouda, M.D,PhD, Study Chair, Aljazeera( Al Gazeera) hospital
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.
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