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Completed

NCT Number: NCT07513480

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 .

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Key information

Conditions

PCOS

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyproterone Acetate, Ethinyl Estradiol Drug Combination

Drug

Once daily Cyclically for 3 months

metformin 500 mg

Drug

Thrice daily for three months

Myoinositol 750mg

Dietary Supplement

Thrice daily for three months

Primary outcomes

  1. Ovarian response by Transvaginal sonography on Day 12-14

    Time frame: 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)

  2. 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

    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

  3. Serum progesterone on Day 21

    Time frame: 3 months cyclically

    more than 3ng/mL willl be considered as ovulated

Secondary outcomes

  1. Pregnancy

    Time frame: 3 months cyclically

    Urine pregnancy kit test positive

Sponsors and collaborators

Lead sponsor

Mst.Sumyara Khatun

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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