Ovarian Hyperstimulation Syndrome Using Calcium Infusion

Study Overview
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Brief Summary
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the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART

Detailed Description
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Among assisted reproductive technologies (ART), ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication affects up to 30% of women undergoing ART and caries high risks of morbidity and mortality. Women with age younger than 35 years, those with history of polycystic ovary syndrome (PCOS), or having a history of previous OHSS are more susceptible to develop OHSS

Official Title
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Ovarian Hyper Stimulation Syndrome Using Calcium Infusion

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: Calcium intravenous infsuion
* 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. and Insulin-dependent diabetes Thyroid 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: 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium intravenous infusion<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 | Drug: Calcium intravenous infsuion<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>|
| Placebo Comparator: saline<br>0.9 % saline intravenous infusion | Drug: 0.9 % saline<br>* 0.9 % saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHSS rate | ovarain hyperstimulation syndrome | one year | 

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