Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome

OHSS Clinical Trial

Official title:

Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875587
• Other study ID #: Cabergoline/calcium gluconate
• Status: Completed
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Aljazeera Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• OHSS
• Ovarian Hyperstimulation Syndrome

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Aljazeera hospital	Giza
Egypt	Riyadh Fertility and Reproductive Health center	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate or severe ovarian hyperstimulation syndrome		Within 4 weeks of HCG adminstration
Secondary	The Number of Participants Who Achieved Ongoing Pregnancy		18 weeks after embryo transfer