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

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 .

Study Overview

• Status: Completed
• Conditions: PCOS
• Intervention / Treatment: Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination; Drug: Metformin 500 mg; Dietary supplement: Myoinositol 750mg

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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Shahbag
    • Dhaka, Shahbag, Bangladesh, 1000
      • Bangladesh Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination; Once daily Cyclically for 3 months; Drug: Metformin 500 mg; Thrice daily for three months; Dietary supplement: Myoinositol 750mg; Thrice daily for three months
Active Comparator: 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.	Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination; Once daily Cyclically for 3 months; Drug: Metformin 500 mg; Thrice daily for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Urine pregnancy kit test positive	3 months cyclically

Collaborators and Investigators

• Sponsor: Mst.Sumyara Khatun

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Actual): November 12, 2025
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PCOS ovarian response
• Additional Relevant MeSH Terms: Organic Chemicals; Carbohydrates; Alcohols; Biguanides; Guanidines; Amidines; Sugar Alcohols; Metformin; Inositol; Cyproterone acetate, ethinyl estradiol drug combination
• Other Study ID Numbers: 5159 (Other Identifier: COMITATO ETICO TERRITORIALE LOMBARDIA 3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No