Pretreatment With CPA-EE, Metformin and Myoinositol in PCOS With High AMH

Mst.Sumyara Khatun68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PCOS

Interventions

Cyproterone Acetate, Ethinyl Estradiol Drug CombinationDRUG

Once daily Cyclically for 3 months

Metformin 500 mgDRUG

Thrice daily for three months

Myoinositol 750mgDIETARY_SUPPLEMENT

Thrice daily for three months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bangladesh Medical University

Dhaka, Shahbag, Bangladesh

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 3 months cyclically

Secondary Outcomes

Pregnancy

Urine pregnancy kit test positive

Time frame: 3 months cyclically

Data from ClinicalTrials.gov

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