PCOS
Conditions
Keywords
PCOS ovarian response
Brief summary
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 .
Detailed description
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
Interventions
Once daily Cyclically for 3 months
DRUGMetformin 500 mg
Thrice daily for three months
DIETARY_SUPPLEMENTMyoinositol 750mg
Thrice daily for three months
Sponsors
Mst.Sumyara Khatun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label parallel design randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* PCOS * 18-35 years. * Body Mass Index (BMI): 18.5-29.9 kg/m². * Infertility. * Serum AMH level ≥ 5ng/ml .
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian response by Transvaginal sonography on Day 12-14 | 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 | 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 | 3 months cyclically | more than 3ng/mL willl be considered as ovulated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 3 months cyclically | Urine pregnancy kit test positive |
Countries
Bangladesh
Outcome results
None listed