Pretreatment With CPA-EE, Metformin and Myoinositol in PCOS With High AMH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Ovarian response by Transvaginal sonography on Day 12-14
研究概览
简要总结
Women with PCOS with high AMH randomly allocated into group A & B.Cyproterone acetate plus ethinyl estradiol,metformin & myoinositol in group A and Cyproterone acetate plus ethinyl estradiol & metformin are given in group B.Then letrozole 5 mg day 2 to day 6 is given & ovarian response is seen in day 12 for 3 subsequent 3 months .
详细描述
Women with PCOS with high AMH randomly allocated into group A & B.Cyproterone acetate plus ethinyl estradiol once daily ,metformin 500 mg 3 times daily & myoinositol 750 mg 3 times daily for 3 months in group A and Cyproterone acetate plus ethinyl estradiol once daily ,metformin 500 mg 3 times daily are given in group B. .Then letrozole 5 mg day 2 to day 6 is given & ovarian response is seen in day 12 for 3 subsequent 3 months .Ovarian response is seen by day 12 folliculometry -mature follice ,developinf follicle and endometrial thickness and day 21 serum progesterone
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-35 years.
- •Body Mass Index (BMI): 18.5-29.9 kg/m².
- •Infertility.
- •Serum AMH level ≥ 5ng/ml .
排除标准
- •Serum AMH level > 10 ng/ml
- •Endocrine disorder (Hyperprolactinaemia,Uncontrolled hypothyroidism , Diabetes mellitus (DM) type 2,congenital adrenal hyperplasia,cushing syndrome)
- •Any known case of pulmonary,cardiac,hepatic & renal disease
- •Women having metformin or other drug that could influence hormone metabolism at least 3 months before the study
- •Any contraindications to metformin, myoinositol, letrozole & CPA-EE ie. obesity, thromboembolism, breast carcinoma etc & hypersensitivity to these drugs.
- •Women with infertility other than anovulation due to PCOS(bilateral tubal block,uterine factor,endometriosis)
- •Abnormal semen parameter.
研究组 & 干预措施
Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily & Myoinositol 750 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
干预措施: Myoinositol 750mg (Dietary Supplement)
Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily & Myoinositol 750 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
干预措施: Cyproterone Acetate, Ethinyl Estradiol Drug Combination (Drug)
Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
干预措施: Cyproterone Acetate, Ethinyl Estradiol Drug Combination (Drug)
Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily & Myoinositol 750 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
干预措施: Metformin 500 mg (Drug)
Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
干预措施: Metformin 500 mg (Drug)
结局指标
主要结局
Ovarian response by Transvaginal sonography on Day 12-14
时间窗: 3 months cyclically
Primary outcome variables Ovarian response by Transvaginal sonography on Day 12-14) Proportion of participants having developing follicles( ≥14 mm) Proportion of participants having mature follicle (18 mm -25 mm) Endometrial thickness (ET)(7 mm or more) Ovulation rate (By mid-luteal serum progesterone 3 ng/ml or more)
presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
时间窗: presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
Serum progesterone on Day 21
时间窗: 3 months cyclically
more than 3ng/mL willl be considered as ovulated
次要结局
- Pregnancy(3 months cyclically)
研究者
Mst.Sumyara Khatun
Medical Officer
Bangladesh Medical University