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In Vitro Oocyte Maturation With Autologous Exosomes in Women

NCT07249411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-25

No results posted yet for this study

Summary

This study is a preliminary, prospective, randomized, controlled clinical trial designed to evaluate the safety and feasibility of supplementing in vitro maturation (IVM) media with autologous exosomes in women with diminished ovarian reserve undergoing assisted reproductive technology. The purpose of the study is to determine whether autologous exosomes can support the meiotic progression of immature metaphase I oocytes during a 24-36 hour culture period and to establish whether the intervention is safe, biologically feasible, and suitable for further clinical evaluation. Mature oocytes obtained after culture are fertilized using intracytoplasmic sperm injection, and resulting embryos are cryopreserved for future transfer in a subsequent phase of the research. No embryo transfer is performed during this preliminary phase.

Conditions

  • Diminished Ovarian Reserve

Interventions

OTHER

MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system

MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system

Sponsors & Collaborators

  • Biotech Fertility C.A.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
38 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249411 on ClinicalTrials.gov