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Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF

NCT07085312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-25

No results posted yet for this study

Summary

Evaluating the Efficacy of Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF

Summary:

This is a prospective, randomized controlled trial designed to assess whether supplementing standard IVF culture media with exosomes can improve the short-term in vitro maturation (IVM) of immature MI oocytes in poor ovarian responder patients.

Sixty women aged 35-42 who meet Bologna criteria for poor ovarian response will be recruited and randomized into two groups:

Control group: MI oocytes cultured in standard IVF media.

Intervention group: MI oocytes cultured in IVF media supplemented with 10 µg of GMP-certified exosomes per well.

The primary outcome is the proportion of MI oocytes maturing to MII within 4 hours. Secondary outcomes include fertilization rates, embryo quality, blastocyst development, and clinical pregnancy rates.

This study aims to explore a novel approach to improving oocyte yield and embryo development in poor responder IVF cycles, potentially reducing the need for repeated treatments and enhancing patient outcomes.

Conditions

  • Poor Ovarian Response
  • Female Infertility of Other Origin
  • Oocyte Immaturity

Interventions

PROCEDURE

Exosome-Enriched IVF Culture

IVF culture media supplemented with 10 µg per well of GMP-certified exosomes (Exosmart or equivalent). Retrieved MI oocytes are cultured in this media for up to 4 hours to assess progression to MII.

Sponsors & Collaborators

  • Fertiaguerrevere

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-02
Primary Completion
2024-07-30
Completion
2025-01-28

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 NCT07085312 on ClinicalTrials.gov