Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Polycystic Ovary Syndrome
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Umbilical Cord Mesenchymal Stem Cell, Secretome
Eligibility Criteria
Inclusion Criteria:
- PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
- Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score >8)
- Patients with Free Androgen Index (FAI) >4 and ovary polycystic from USG transvaginal
- Patients with Homeostatic (HOMA) IR score ≥ 1.7
Exclusion Criteria:
- Patients who are allergic to component of WJ-MSC or Secretome.
- Patients who are not currently on hormon treatment of other resistance treatment.
- Refusing or not participating in part / all of the research process.
- Patients with positive diagnosis of hepatitis A,B,C, and HIV
Sites / Locations
- PT Prodia StemCell IndonesiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
WJ-MSCs
Secretomes
WJ-MSCs and Secretomes
Control
Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
Patients will be given tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
Patients will be given Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.