Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial).
This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study.
Statistical analysis of the data will be performed .
详细描述
Metformin is usually used with induction regimen in patients with PCOS as it improves ovulation rate by direct effect on ovarian tissue,Metformin will be used in combination with clomiphene citrate in women with unexplained infertility with previous failed cycle to asses its efficacy on clinical pregnancy rate.
Study will be conducted in infertility clinic,Ain Shams university maternity hospital.Study population comprises women with unexplained infertility aged 20-35 years with total sample size of 170 who willbe randomized into two groups with 85 women in each group.
Group A:is case group who will receive metformin plus clomiphene citrate. Group B:is control group who will receive clomiphene citrate plus placebo. Metformin will be started at time of booking and will be continued till pregnancy is confirmed in a dose of 850 mg twice daily in form of tablet.
Vaginal ultrasound is done for all in day 2 to exclude presence of ovarian cyst and to identify normal appearance of ovaries,then folliculometry on day 9 followed by serial folliculometry every other day till reaching dominant follicle 18 mm or more where HCG intramuscular injection will be given in a dose of 10000 iu .
serum pregnancy test will be done after 16 days. Transvaginal ulterasound will be done on day 35.
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 (Participant)
盲法说明
Each of the consecutive women numbers will be written on sequentially numbered opaque sealed envelope that contains the assignment code.At the time of procedure,the responsible investigator will open the envelope to reveal the assignment,and she will introduce the planned method. Monitoring and follow up will be done. After enrollment,the cases will be randomly allocated into two groups.
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
- •Age 20-35 years old.
- •BMI 20-<30
- •FSH 12 IU/L or less
- •Normal transvaginal ulterasound(normal uterus and ovaries with no congenital anomalies).
- •Patent fallopian tubes assesd by hysterosalpingogram or laparoscopy.
- •Normal semen analysis.
- •Infertile women with history of previous failed induction cycle.
排除标准
- •Women younger than 20 or elder than 35 years old.
- •Women with BMI equal to or more than
- •Uncorrected congenital or acquired uterine anomaly.
- •Other causes of infertility rather than unexplained infertility.
- •Patient with Diabetes Mellitus.
研究组 & 干预措施
Metformin Group
Will receive metformin plus clomiphene citrate
干预措施: Metformin (Drug)
Metformin Group
Will receive metformin plus clomiphene citrate
干预措施: Clomiphene Citrate (Drug)
Placebo
Will receive placebo plus clomiphene citrate.
干预措施: Placebo (Drug)
Placebo
Will receive placebo plus clomiphene citrate.
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: one cycle for each woman (28 days in average)
Diagnosis of pregnancy by transvaginal ulterasound
次要结局
未报告次要终点
研究者
Elham Raafat
resident of obstetric and gynecology
Ain Shams University