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

A

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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