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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
combination theraphy
RS AMC Yogyakarta
Yogyakarta, DIY, Indonesia
RECRUITINGChange 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)
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)
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)
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)
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)
Menstrual cycle regularity during the 3-month treatment period
Proportion of participants who experience monthly menstrual bleeding during the 3-month treatment period.
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Time frame: During the 3-month treatment period