CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration systemother
Likely dose
MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration systemfrom record
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Search/NCT07249411
NCT07249411N/ACompleted

In Vitro Oocyte Maturation With Autologous Exosomes in Women With Low Ovarian Reserve: Preliminary Phase of a Prospective Randomized Clinical Study

Biotech Fertility C.A.·interventional·Posted Nov 25, 2025·Updated Nov 25, 2025

In Brief

A clinical study evaluating MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system for Diminished Ovarian Reserve. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesVenezuela
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 25, 2025
Enrollment StartJan 2, 2023
Primary CompletionJan 31, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7 months ago

Interventions

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

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