Calcium for Prevention of Ovarian Hyperstimulation Syndrome

Study Overview
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Brief Summary
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There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS & the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect & the real mechanism for its action.

Detailed Description
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The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI. Group (A)active group: administration of 10% Intravenous 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 was performed within 30 minutes. Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes

Official Title
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Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: calcium
* Drug: 0.9 % saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertile women aged 20 to 38 years. BMI ranged from 18 to 40. serum FSH within normal limits( 1-12IU /l) presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration. Exclusion Criteria: endocrinopathies. a systemic disease. using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists. patients need coasting for high risk of OHSS. patients need cycle cancellation. severe male infertility requiring testicular sperm extraction.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>0.9% saline intravenous infusion | Drug: 0.9 % saline<br>* 0.9 % saline intravenous infusion<br>|
| Experimental: calcium<br>Calcium intravenous infusion | Drug: calcium<br>* intravenous infusion of 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 were administered in study group. Intravenous infusion was performed within 30 minutes<br>* Other names: Calcium intravenous infsuion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHSS rate | ovarain hyperstimulation syndrome | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OHSS, ICSI, calcium injection