Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Study Overview
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Brief Summary
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Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention

Detailed Description
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Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days

Official Title
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Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial

Conditions
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Ovarian Hyperstimulation

Intervention / Treatment
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* Drug: Oral Cabergoline
* Drug: Calcium Gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin Exclusion Criteria:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium infusion<br>10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days | Drug: Calcium Gluconate<br>* Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days<br>* Other names: Calcium;|
| Active Comparator: Oral Cabergoline<br>Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily | Drug: Oral Cabergoline<br>* Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days<br>* Other names: Cabergamon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of ovarian hyperstimuation syndrome | Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration | 20 days from ovum pick up day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of ovarian hyperstimuation syndrome and severity | Clinical severity either mild ,moderate or severe and its type either early or late onst | 20 days from ovum pick up day | 
| Chemical pregnancy | Positive human chorionic Gonadotropin in blood | 14 day from embryos transfer day | 
| Clinical pregnancy | Intrauterine gestational sac | 5 week from embryos transfer day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium infusion, Cabergoline