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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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OHSS

Intervention / Treatment
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* Drug: Cabergoline
* Drug: Calcium gluconate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cabergoline group<br>Cabergoline is administered starting on the day of HCG administration. | Drug: Cabergoline<br>* 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<br>|
| Experimental: Calcium gluconate infusion group<br>Calcium gluconate is administered starting on the day of HCG administration. | Drug: Calcium gluconate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate or severe ovarian hyperstimulation syndrome |  | Within 4 weeks of HCG adminstration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Achieved Ongoing Pregnancy |  | 18 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OHSS, Infertility, Cabergoline, Calcium gluconate, IVF-ET