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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interprofessional collaboration treatment for PCOS at RS AMC Yogyakarta | No Intervention | to know the effect of interproffessional collaboration in pcos patient. And also to try give the best treatment for pcos patient | |
| The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS | Experimental | To compare the effectiveness of treatment for women with pcos syndrome between inlacin and clomiphene citrat with knowing the AMH first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dlbs 3233 , clomifen citrat | Combination Product | combination theraphy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline cycle (Day 12) to Month 3 cycle (Day 12) |
| Change in number of mature follicles on Day 12 ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3 months |
| Change in ovarian volume on ultrasound during annual follow-up |
Inclusion Criteria:
Exclusion Criteria:
women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| prastika candra, s1 | Contact | 62882003145445 | prastikacandra13@gmail.com | |
| nazdifah fitriyani, s1 | Contact | 6282223338737 | nadzifahfitri37@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| UMY Yogyakarta | muhammadiyah university of yogyakarta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RS AMC Yogyakarta | Recruiting | Yogyakarta | DIY | 55253 | Indonesia |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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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 | 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 | Proportion of participants who experience monthly menstrual bleeding during the 3-month treatment period. | During the 3-month treatment period |
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 | 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) |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |