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临床试验/NCT04606082
NCT04606082Unknown不适用

Intra Uterine Injection of Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor at Ovum Pick up Day Significantly Increase Implantation Rate and Pregnancy Rate in Intra Cytoplasmic Sperm Injection

Al-Azhar University0 个研究点目标入组 200 人开始时间: 2020年10月30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
clinical pregnancy rate

研究概览

简要总结

Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome.

详细描述

Two hundred females with history of recurrent implantation failure and undergoing Intracytoplasmic Sprem injection (ICSI) were randomized into two groups; the first group (100 patients) received intrauterine Granulocyte colony stimulating factor (GCSF) and the second group (100) received intrauterine Human Chorionic Gonadotropin (HCG) at ovum pick up day. The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.

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
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females suffering from recurrent implantation failure and undergoing ICSI

排除标准

  • presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders

研究组 & 干预措施

Group 1

Experimental

Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day

干预措施: Granulocyte Colony Stimulated Factor (Drug)

Group 2

Active Comparator

500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day

干预措施: Human Chorionic Gonadotropins (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: after 14 days from positive pregnancy test

Clinical pregnancy was evaluated by high HCG levels

次要结局

  • Gestational sac imaging(6 weeks of pregnancy)

研究者

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

Elsayed Eldesouky

Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo

Al-Azhar University

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