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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02875587

Enrollment

170

Registered

2016-08-23

Start date

2016-10-31

Completion date

2018-12-31

Last updated

2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OHSS

Keywords

OHSS, Infertility, Cabergoline, Calcium gluconate, IVF-ET

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.

Interventions

DRUGCabergoline

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

DRUGCalcium 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 37 Years

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.

Design outcomes

Primary

Measure	Time frame
Moderate or severe ovarian hyperstimulation syndrome	Within 4 weeks of HCG adminstration

Secondary

Measure	Time frame
The Number of Participants Who Achieved Ongoing Pregnancy	18 weeks after embryo transfer

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026