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NCT Number: NCT05279768

Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

PT Prodia StemCell Indonesia

Jakarta, Indonesia

About this study

The investigator hypothesized that PCOS patients with insulin resistance given combination of UC-MSCs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle and fertility. All group will be observed every 1,3, and 6 months after injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UC-MSCs

Biological

Treatment with 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.

Secretomes

Biological

Treatment with tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.

UC-MSCs and Secretomes

Biological

Treatment with 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.

Control

Biological

Treatment with Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.

Primary outcomes

  1. Blood serum sample

    Time frame: Follicular phase on day 10-12

    Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.

  2. Free Androgen index (FAI)

    Time frame: Follicular phase on day 10-12

    Free Androgen index (FAI) is calculated by total testosterone x100/SHBG

  3. Insulin, Glucose Plasma, and Insulin Resistance

    Time frame: Follicular phase on day 10-12

    insulin resistance is calculated by the method: HOMA: HOMA-IR = (insulin x glucose) / 22.5 and HOMA-ß = (20 x insulin) / glucose - 3.5.

  4. Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)

    Time frame: Follicular phase on day 10-12, and 1,3,6 months after stem cells

    Parameter in testing the cytokine/adipokine/hormone profile

  5. Leptin and Adiponectine Profile

    Time frame: 1,3,6 months after stem cells

    Parameter in testing the cytokine/adipokine/hormone profile

  6. TNFα, IL-1 β, IL-6, IL-10 Profile

    Time frame: 1,3,6 months after stem cells

    Parameter in testing the cytokine/adipokine/hormone profile

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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