The Effect of Therapy Combination in PCOS With Dlbs 3233

February 4, 2026 updated by: Inlacinpenelitian

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • DIY
      • Yogyakarta, DIY, Indonesia, 55253
        • Recruiting
        • RS AMC Yogyakarta
        • Contact:
        • Contact:
          • amc yogyakarta
          • Phone Number: 628170618400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • married agree to join this research

Exclusion Criteria:

  • dis agree to join research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Interprofessional collaboration treatment for PCOS at RS AMC Yogyakarta
to know the effect of interproffessional collaboration in pcos patient. And also to try give the best treatment for pcos patient
Experimental: The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS
To compare the effectiveness of treatment for women with pcos syndrome between inlacin and clomiphene citrat with knowing the AMH first
Combination product: dlbs 3233 , clomifen citrat
combination theraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
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.
Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline cycle (Day 12) to Month 3 cycle (Day 12)
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.
Baseline cycle (Day 12) to Month 3 cycle (Day 12)
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.
Baseline cycle (Day 12) to Month 3 cycle (Day 12)
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.
During the 3-month treatment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 months
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).
Up to 5 years (annual follow-up)
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.
Up to 5 years (annual follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inlacinpenelitian

Investigators

  • Study Director: UMY Yogyakarta, muhammadiyah university of yogyakarta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inlacinpenelitian

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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