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

NCT07085312 | Completed DMC

• 1 other identifier: J-298384255-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

exosomes; in vitro maturation; oocyte maturation; IVF; poor ovarian responders

Outcome Measures

Primary Outcomes (1)

• Proportion of MI Oocytes Achieving MII Maturation

  The primary outcome is the percentage of retrieved MI oocytes that progress to MII after 2-4 hours of culture in exosome-enriched versus standard IVF media. Oocyte maturation is assessed morphologically under an inverted microscope.

  Within 4 hours post-culture

Secondary Outcomes (1)

• Fertilization Rate

  18-20 hours post-ICSI

Study Arms (1)

Ovarian Stimulation with MI Oocyte Allocation to Exosome vs. Standard Media

EXPERIMENTAL

All participants undergo controlled ovarian stimulation and oocyte retrieval following a standard antagonist protocol. Retrieved MI oocytes from each patient are then allocated to two different in vitro culture conditions: (1) standard IVF media, and (2) IVF media supplemented with 10 µg of GMP-certified exosomes per well. This design allows within-patient comparison of oocyte maturation, fertilization, and embryo development outcomes under the two culture environments.

Procedure: Exosome-Enriched IVF Culture

Interventions

Exosome-Enriched IVF Culture PROCEDURE

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.

Ovarian Stimulation with MI Oocyte Allocation to Exosome vs. Standard Media

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: Female, Self-identified women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 35 to 42 years
• Undergoing IVF with an antagonist protocol
• Meet at least two Bologna criteria for poor ovarian response
• Provide written informed consent -

You may not qualify if:

• Severe male factor infertility requiring surgical sperm retrieval
• Known untreated hydrosalpinx
• Uterine anomalies that impair implantation
• Known chromosomal abnormalities
• Participation in another investigational study within 3 months

Sponsors & Collaborators

• Fertiaguerrevere: lead

Study Sites (1)

Fertiaguerrevere Fertility

Caracas, Distrito Federal, 1018, Venezuela

Location

Related Publications (2)

• Song J, Guo X, Zhang B, Zhang Q, Han Y, Cao D, Yao Y. Human Umbilical Cord Mesenchymal Stem Cells Derived Exosomes Improved The Aged Mouse IVM Oocytes Quality. Reprod Sci. 2024 Sep;31(9):2808-2819. doi: 10.1007/s43032-024-01566-z. Epub 2024 Apr 30.

  PMID: 38689080 RESULT

• Melo P, Navarro C, Jones C, Coward K, Coleman L. The use of autologous platelet-rich plasma (PRP) versus no intervention in women with low ovarian reserve undergoing fertility treatment: a non-randomized interventional study. J Assist Reprod Genet. 2020 Apr;37(4):855-863. doi: 10.1007/s10815-020-01710-z. Epub 2020 Feb 7.

  PMID: 32030554 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: "Not applicable. No additional parties are masked in this trial."
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 25, 2025
• Study Start: July 2, 2023
• Primary Completion: July 30, 2024
• Study Completion: January 28, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)