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

Phase 2

Completed

• Conditions: OHSS
• Interventions: Drug: Cabergoline; Drug: Calcium gluconate

• Registration Number: NCT02875587
• Lead Sponsor: Aljazeera Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-23
• Study Start: 2016-10
• Primary Completion: 2018-08
• Status Verified: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2018-12-25
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabergoline group	Cabergoline	Cabergoline is administered starting on the day of HCG administration.
Calcium gluconate infusion group	Calcium gluconate	Calcium gluconate is administered starting on the day of HCG administration.

Primary Outcome Measures

Name	Time	Method
Moderate or severe ovarian hyperstimulation syndrome	Within 4 weeks of HCG adminstration

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Achieved Ongoing Pregnancy	18 weeks after embryo transfer

Trial Locations

Locations (2)

Aljazeera hospital; 🇪🇬 Giza, Egypt

Riyadh Fertility and Reproductive Health center; 🇪🇬 Giza, Egypt