Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients Wi… (NCT05279768) | Clinical Trial Compass
CompletedPhase 1/2
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Indonesia44 participantsStarted 2022-09-01
Plain-language summary
The purpose of this study is to investigating the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely UC-MSCs treatment, secretomes treatment, UC-MSCs and secretomes treatment, and control.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used stem cells and secretomes as a treatment for PCOS with insulin resistance — can you explain what secretomes are and whether this kind of approach has shown any meaningful changes in hormone levels like SHGB, AMH, or the Free Androgen Index in the results so far?
2Since this was a Phase 1/2 trial that has now completed, what does that phase combination mean for how much we know about safety versus effectiveness, and would it be premature to consider this approach outside of a research setting?
3The trial tracked inflammation markers like TNFα, IL-6, and IL-10 alongside insulin resistance measures — does that suggest this treatment was targeting the underlying metabolic causes of my PCOS, and how does that compare to what my current treatment plan is addressing?
4Given that this trial has completed, has any data been published yet, and would you be able to review the results with me to see whether the outcomes — like changes in insulin resistance or leptin and adiponectin levels — are relevant to my specific situation?
5Are there other active trials or established treatments for PCOS with insulin resistance that I should be considering alongside or instead of waiting to see where this completed research leads?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood serum sample
Timeframe: Follicular phase on day 10-12
2
Free Androgen index (FAI)
Timeframe: Follicular phase on day 10-12
3
Insulin, Glucose Plasma, and Insulin Resistance
Timeframe: Follicular phase on day 10-12
4
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
Timeframe: Follicular phase on day 10-12, and 1,3,6 months after stem cells