Polycystic Ovary Syndrome
Conditions
Keywords
pcos, dlbbs 3233, clomifen citrat
Brief summary
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
Detailed description
to know the effect of combination dlbs 3233 theraphy and clomifen citrat in cases PCOS to control menstrual cycle and weight loss
Interventions
COMBINATION_PRODUCTdlbs 3233 , clomifen citrat
combination theraphy
Sponsors
Inlacinpenelitian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
No
Inclusion criteria
* married agree to join this research
Exclusion criteria
* dis agree to join research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HOMA-IR | 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. |
| Change in serum AMH concentration | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in total follicle count on Day 12 ultrasound | 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. |
| Change in number of mature follicles on Day 12 ultrasound | 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. |
| Change in mature follicle diameter on Day 12 ultrasound | 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. |
| Menstrual cycle regularity during the 3-month treatment period | During the 3-month treatment period | Proportion of participants who experience monthly menstrual bleeding during the 3-month treatment period. |
Countries
Indonesia
Contacts
CONTACTprastika candra, s1
CONTACTnazdifah fitriyani, s1
STUDY_DIRECTORUMY Yogyakarta
muhammadiyah university of yogyakarta
Outcome results
None listed