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NCT Number: NCT07403201

The Effect of Therapy Combination in PCOS With Dlbs 3233

The effect of combination therapy dlbs 3233 and clomifen citrate vs clomifen citrate on homa ir, maturation follicle, and menstrual cycle in PCOS cases at Muhammadiyah Asri Medical Center Hospital

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

Up to 45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

to know the effect of combination dlbs 3233 theraphy and clomifen citrat in cases PCOS to control menstrual cycle and weight loss

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • married agree to join this research

Exclusion criteria

  • dis agree to join research

Treatment and study plan

dlbs 3233 , clomifen citrat

Combination Product

combination theraphy

Primary outcomes

  1. Change in HOMA-IR

    Time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)

    HOMA-IR will be used to assess insulin resistance. Fasting glucose and fasting insulin will be collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment, and HOMA-IR will be calculated as a single index value.

  2. Change in serum AMH concentration

    Time frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)

    Serum anti-mullerian hormone (AMH) will be measured from venous blood collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment to assess ovarian function response.

Secondary outcomes

  1. Change in total follicle count on Day 12 ultrasound

    Time frame: Baseline cycle (Day 12) to Month 3 cycle (Day 12)

    Total number of follicles will be assessed by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.

  2. Change in number of mature follicles on Day 12 ultrasound

    Time frame: Baseline cycle (Day 12) to Month 3 cycle (Day 12)

    Number of mature follicles assessed by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.

  3. Change in mature follicle diameter on Day 12 ultrasound

    Time frame: Baseline cycle (Day 12) to Month 3 cycle (Day 12)

    Mature (dominant) follicle diameter will be measured by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.

  4. Menstrual cycle regularity during the 3-month treatment period

    Time frame: During the 3-month treatment period

    Proportion of participants who experience monthly menstrual bleeding during the 3-month treatment period.

Other outcomes

  1. Change in body mass index (BMI) during treatment

    Time frame: Baseline to 3 months

    BMI calculated using measured weight and height at baseline and at the end of the 3-month treatment period.

  2. Change in ovarian volume on ultrasound during annual follow-up

    Time frame: Up to 5 years (annual follow-up)

    Ovarian volume measured by transvaginal ultrasound at each annual follow-up visit after completion of the 3-month treatment period. Ovarian volume recorded as a numeric value (cm³).

  3. Change in BMI during annual follow-up

    Time frame: Up to 5 years (annual follow-up)

    BMI calculated at each annual follow-up visit after completion of the 3-month treatment period using measured weight and height.

Study contacts

Contact information is provided by the study sponsor or research team.

nazdifah fitriyani, s1

CONTACT

[email protected]

6282223338737

prastika candra, s1

CONTACT

[email protected]

62882003145445

Sponsors and collaborators

Lead sponsor

Inlacinpenelitian

Other

Registry information

Official study title

The Effect of Combination Therapy Dlbs 3233 and Clomifen Citrate vs Clomifen Citrate on Homa ir, Maturation Follicle, and Menstrual Cycle in PCOS Cases at Muhammadiyah Asri Medical Center Hospital

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 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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