The Effect of Therapy Combination in PCOS With Dlbs 3233
ConditionPolycystic Ovary Syndrome
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
AgeUp to 45
SponsorInlacinpenelitian
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
married agree to join this research
Disqualifiers
dis agree to join research
Trial design
Design model
Parallel
Treatments tested in this trial
dlbs 3233 , clomifen citrat
Combination productcombination theraphy
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Interprofessional collaboration treatment for PCOS at RS AMC YogyakartaNo intervention 0 interventions
Group B: The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in HOMA-IR
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.
Time frame
Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)2
Change in serum AMH concentration
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.
Time frame
Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)Secondary outcomes
1
Change in total follicle count on Day 12 ultrasound
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.
Time frame
Baseline cycle (Day 12) to Month 3 cycle (Day 12)2
Change in number of mature follicles on Day 12 ultrasound
Number of mature follicles assessed by transvaginal ultrasound on Day 12 of the menstrual cycle at baseline and after 3 months of treatment.
Time frame
Baseline cycle (Day 12) to Month 3 cycle (Day 12)3
Change in mature follicle diameter on Day 12 ultrasound
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.
Time frame
Baseline cycle (Day 12) to Month 3 cycle (Day 12)4
Menstrual cycle regularity during the 3-month treatment period
Proportion of participants who experience monthly menstrual bleeding during the 3-month treatment period.
Time frame
During the 3-month treatment periodOther outcomes
1
Change in body mass index (BMI) during treatment
BMI calculated using measured weight and height at baseline and at the end of the 3-month treatment period.
Time frame
Baseline to 3 months2
Change in ovarian volume on ultrasound during 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).
Time frame
Up to 5 years (annual follow-up)3
Change in BMI during annual follow-up
BMI calculated at each annual follow-up visit after completion of the 3-month treatment period using measured weight and height.
Time frame
Up to 5 years (annual follow-up)Sponsors and contacts
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Source ClinicalTrials.gov