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NCT06773572: Exosom2024-1

Use of Autologous Exosomes vs Platelet Growth Factors to Regenerate the Ovary in Women With Infertility (Exosomas2024-1)

Completed NA Last updated 14 January 2025
What this trial tests

NA trial testing Autologous Exososomes procedure obtained from the patients' own platelets. in Infertility, Female in 30 participants. Completed in 30 September 2024.

Timeline
3 January 2024
Primary endpoint
30 September 2024
30 September 2024

Quick facts

Lead sponsorBiotech Fertility C.A.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date3 January 2024
Primary completion30 September 2024
Estimated completion30 September 2024
Sites1 location across Venezuela

Drugs / interventions tested

Conditions studied

Sponsor

Biotech Fertility C.A.

Who can join

Adults 38 to 48, female only, with Infertility, Female or Reproductive Techniques, Assisted. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ovarian stromal fibrosis resulting from each ovulation and due to aging is characterized by a decrease in hyaluronic acid concentrations, loss of synthesis and migration proteins CD63 and CD81, decreased miRNA125, miRNA21, miRNA132 and miRNA199. Also, enzymatic alterations affecting kinases and mitochondrial sirtuins SIRT3-5 with increased oxygen free radicals preventing the normal maintenance and development of folliculogenesis, leading to the inability to reproduce at advanced ages and accelerating the onset of pathologies secondary to the decrease of ovarian estrogens. Methodology: An observational, prospective, randomized, comparative, double-blind, analytical pilot study in 30 women between 38 and 46 years of age, with diminished ovarian reserve and who refused the egg donation procedure. Three groups were designated: one for autologous exosomes, one for PRP and one with physiological solution.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ovarian Aging: Mechanisms, Age-Related Disorders, and Therapeutic Interventions.
    Liu X, Zhao Y, Feng Y, Wang S, et al · · 2025 · cited 3× · PMID 41256733 · DOI 10.1002/mco2.70481
  2. Comparative analysis of the use of autologous exosomes and platelet-derived growth factors in women with premature ovarian insufficiency and infertility: A prospective, randomized, observational, analytical study.
    Navarro C, Torrecillas Cabrera P, Teppa Garrán A. · · 2025 · cited 3× · PMID 40678344 · DOI 10.1016/j.reth.2025.06.007
  3. Exosomes in oncofertility: emerging roles in chemotherapy-induced reproductive damage and fertility preservation.
    Abady MM, Alshehri B, Aldakhil K, Alqassim A, et al · · 2026 · PMID 41961835 · DOI 10.1530/raf-25-0149

Verify or expand the search:

Other recruiting trials for Infertility, Female

Currently open trials in the same condition.

Other Biotech Fertility C.A. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06773572.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing