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

Aljazeera Hospital

Status and phase: Completed; Phase 2

Conditions: OHSS

Treatments: Drug: Cabergoline; Drug: Calcium gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT02875587

Cabergoline/calcium gluconate

Details and patient eligibility

About

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 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.

Enrollment: 170 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Cabergoline group

Active Comparator group

Description:

Cabergoline is administered starting on the day of HCG administration.

Treatment:

Drug: Cabergoline

Calcium gluconate infusion group

Experimental group

Description:

Calcium gluconate is administered starting on the day of HCG administration.

Treatment:

Drug: Calcium gluconate