Comparative Study Between Granulocyte Colony Stimulating Factor and Human Chorionic Gonadotropin in Patients With History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection (at Ovum Pick up Day)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
One hundred patients who suffered from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were allocated in the study. On ovum pick-up day, 50 of them were intrauterine injected with granulocyte colony-stimulating factor (G-CSF) and the other 50 were injected with intrauterine Human Chorionic Gonadotropins (HCG). The clinical pregnancy rate was evaluated as a primary outcome and ultrasound imaging of the gestational sac was evaluated as a secondary outcome
详细描述
One hundred patients suffering from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were included in the study. The patients were randomly allocated into two groups. The intervention group consisted of 50 patients who received intrauterine injected with granulocyte colony-stimulating factor (G-CSF). The other group (the control group) consisted of 50 patients and injected with intrauterine Human Chorionic Gonadotropins (HCG). Both groups received the interventions at ovum pick-up day. The main outcome was the clinical pregnancy rate which has been evaluated after 2 weeks of the positive pregnancy test. The secondary outcome was an ultrasound image of the gestational sac after 6 weeks of pregnancy.
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
- 否
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
Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment.
干预措施: Granulocyte Colony Stimulated Factor (Drug)
Group 2
Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment.
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
number of pregnancies that is confirmed by both high levels of hCG (the pregnancy hormone) and ultrasound confirmation of a gestational sac or heartbeat (fetal pole)
次要结局
- ultrasound image of Gestational sac(6 weeks of pregnancy)
研究者
Elsayed Eldesouky
Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
Al-Azhar University