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临床试验/NCT05198128
NCT05198128Unknown不适用

Ovarian Hyper Stimulation Syndrome Using Calcium Infusion

Al-Azhar University0 个研究点目标入组 200 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
主要终点
OHSS rate

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • infertile women aged 20 to 38 years. BMI ranged from 18 to
  • 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.

排除标准

  • 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.

研究组 & 干预措施

Calcium intravenous infusion

Experimental

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

干预措施: Calcium intravenous infsuion (Drug)

saline

Placebo Comparator

0.9 % saline intravenous infusion

干预措施: 0.9 % saline (Drug)

结局指标

主要结局

OHSS rate

时间窗: one year

ovarain hyperstimulation syndrome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Said Ali

DR: ahmedsaidali, MCS CANDIDIATE

Al-Azhar University

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