Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets to all participants
详细描述
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •women age 20_35
- •BMI 18_29.9
- •Women with PCOS(diagnosed by using Rotterdam criteria
- •Infertility is cause for seeking tfeatment
排除标准
- •Causes of infertility other than PCOS.
- •patient refusal.
- •Contraindication of any of the drugs used in the study
- •Cause of oligo/anovulation other than PCOS
- •Current or previous (within the last six month) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetics, antiobesity drugs or other hormonal drugs.
研究组 & 干预措施
Group A
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
干预措施: Pioglitazone (Drug)
Group A
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
干预措施: Clomiphene Citrate (Drug)
Group B
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
干预措施: Metformin (Drug)
Group B
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 3 months
Pregnancy rate diagnosed by U/S at five weeks after missed menses
次要结局
未报告次要终点
研究者
Asmaa Abdelbadea Ali Salih
Cairo
Ain Shams University