Effect of Metformin on Non PCO Women Undergoing IVF/ICSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rate of OHSS
研究概览
简要总结
400 Patients will be randomly assigned into two groups after informed consent from every patient.
They will be classified into 2 groups:
Group A ( involves 200 patients ) will receive metformin 850 mg twice daily along the cycle of Intra-cytoplasmic sperm injection (ICSI) Group B ( involve 200 patients) will not receive metformin. They will undergo a cycle of ICSI. Primary outcome of this trial is to detect occurrence of Ovarian Hyper-stimulation Syndrome (OHSS) , while secondary outcomes include quality & number of retrieved
follicles fertilization rate ,ongoing pregnancy rate & endometrial thickness.
详细描述
This study is a prospective, single-blinded (to the outcomes assessor), randomized controlled trial conducted at the In Vitro Fertilization ( IVF) centers of the Departments of Obstetrics & Gynecology, Kasr El-Ainy Hospital and Beni-suef hospital in Cairo University and Beni-suef university,respectively, Egypt, to determine the clinical effect of metformin on ICSI outcomes in non PCO patients. Ethical committee approval was obtained. The study will include 400 infertile patients.
Inclusion criteria :
- Patients subjected to IVF/ICSI aged 20-35 years with long agonist protocol
- history of infertility for at least two years (either primary or secondary)
- normal Thyroid stimulating Hormone (TSH) and prolactin
Exclusion criteria :
- Patients who used metformin in the past 3-months before study
- having medical problems such as kidney or liver diseases
- Severe endometriosis.
- hypo-thalamic amenorrhea.
- Severe male factor( patients with testicular biopsy or those with azoo-spermia).
- Associated uterine factor.
- IVF/ ICSI for sex selection. All patients are informed about the study and consent is given by those who accept to participate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients subjected to IVF/ICSI aged 20-35 years with long agonist protocol
- •history of infertility for at least two years (either primary or secondary)
- •normal TSH and prolactin
排除标准
- •Patients who used metformin in the past 3-months before study
- •having medical problems such as kidney or liver diseases
- •Severe endometriosis.
- •hypothalamic amenorrhea.
- •Severe male factor( patients with testicular biopsy or those with azoospermia).
- •Associated uterine factor.
- •IVF/ ICSI for sex selection.
研究组 & 干预措施
metformin
Group A ( involve 200 patients ) will receive metformin 850 mg twice daily along the cycle of ICSI
干预措施: Metformin (Drug)
结局指标
主要结局
Rate of OHSS
时间窗: 4weeks
The number of cases of Ovarian Hyperstimulation Syndrome per cycle
次要结局
- fertilization rate(4weeks)
- The number of Mature retrieved eggs ( M-I) follicles .(2-4weeks)
- pregnancy rate(4 weeks)
研究者
Amira S Dieb
Assistant professor
Kasr El Aini Hospital