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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 .
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m | Experimental | 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. |
|
| Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyproterone Acetate, Ethinyl Estradiol Drug Combination | Drug | Once daily Cyclically for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian response by Transvaginal sonography on Day 12-14 | 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) | 3 months cyclically |
| 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 | 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 | more than 3ng/mL willl be considered as ovulated | 3 months cyclically |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | Urine pregnancy kit test positive | 3 months cyclically |
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Inclusion Criteria:
Exclusion Criteria:
female,Pocystic ovary syndrome patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangladesh Medical University | Dhaka | Shahbag | 1000 | Bangladesh |
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| ID | Term |
|---|---|
| C032640 | Cyproterone acetate, ethinyl estradiol drug combination |
| D008687 | Metformin |
| D007294 | Inositol |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013402 |
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open label parallel design randomized controlled trial
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| Metformin 500 mg | Drug | Thrice daily for three months |
|
| Myoinositol 750mg | Dietary Supplement | Thrice daily for three months |
|
| Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |