An interventional study of Exosome-Enriched IVF Culture in Poor Ovarian Response, Female Infertility of Other Origin and Oocyte Immaturity, sponsored by Fertiaguerrevere. Completed at 1 site in Venezuela. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Fertiaguerrevere · Not applicable, Interventional, and Basic science
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.
This is a prospective, single-center, randomized controlled trial designed to evaluate the efficacy of exosome-enriched culture media in promoting the short-term in vitro maturation (IVM) of immature oocytes retrieved from poor ovarian responder patients undergoing in vitro fertilization (IVF).
Rationale:
Poor ovarian responders represent a significant clinical challenge in assisted reproductive technology (ART), often yielding a low number of mature metaphase II (MII) oocytes after controlled ovarian stimulation. A substantial proportion of oocytes retrieved in these patients remain at the metaphase I (MI) stage and traditionally show limited capacity for maturation, thereby reducing the pool of oocytes available for fertilization.
Emerging preclinical data and our pilot observations suggest that exosomes-extracellular vesicles containing bioactive molecules such as miRNAs, proteins, and growth factors-play a crucial role in follicular development and may facilitate oocyte meiotic progression. Incorporating exosomes into IVF culture media could therefore represent a novel strategy to enhance in vitro maturation of MI oocytes and improve outcomes in this difficult-to-treat population.
Study Design and Methods:
The study will enroll 60 women aged 35 to 42 years, all meeting at least two Bologna criteria for poor ovarian response. Patients will undergo controlled ovarian stimulation with antagonist protocols and oocyte retrieval approximately 36-37 hours after hCG administration. Retrieved oocytes will be classified as MI or MII.
MI oocytes will be randomized on a per-patient basis into two groups:
Control group: MI oocytes cultured in pre-equilibrated Cook IVF media without additional supplementation.
Intervention group: MI oocytes cultured in the same media supplemented with 10 µg/well of GMP-certified exosomes (sourced from Exosmart or an equivalent validated supplier).
Oocytes will be monitored for progression from MI to MII at intervals up to 4 hours. Subsequent ICSI will be performed on matured oocytes, and resulting embryos will be cultured to blastocyst stage following standard laboratory protocols.
Outcomes:
The primary endpoint is the proportion of MI oocytes achieving maturation to MII within 4 hours of culture.
Secondary endpoints include fertilization rates (2PN formation), day 3 and blastocyst morphological grading, implantation rates, and clinical pregnancy rates per embryo transfer.
Statistical Considerations:
Data will be analyzed using chi-square or Fisher's exact tests for categorical variables such as maturation and fertilization rates. Logistic regression may be used to adjust for confounding factors such as patient age, baseline AMH, and gonadotropin dose. A p-value \<0.05 will be considered statistically significant.
Ethical Considerations:
All patients will provide written informed consent before participation. The study will be conducted in compliance with the Declaration of Helsinki, local regulations, and Good Clinical Practice (GCP) guidelines. The protocol will be reviewed and approved by the appropriate Institutional Review Board (IRB) prior to initiation.
Potential Impact:
By investigating the role of exosome supplementation in improving the maturation of MI oocytes, this study seeks to expand the pool of usable oocytes in poor responder IVF cycles. This could translate to higher embryo availability, reduced cycle cancellations, and ultimately improved pregnancy outcomes in a patient group historically characterized by low success rates.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 378 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →This is the only study on the registry with Fertiaguerrevere as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:Inclusion Criteria:
Women aged 35 to 42 years
Undergoing IVF with an antagonist protocol
Meet at least two Bologna criteria for poor ovarian response
Provide written -
Exclusion Criteria:
Severe male factor infertility requiring surgical sperm retrieval
Known untreated hydrosalpinx
Uterine anomalies that impair implantation
Known chromosomal abnormalities
Participation in another study within 3 months
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: Within 4 hours post-culture
Fertilization Rate
Percentage of matured MII oocytes that exhibit normal 2PN fertilization after ICSI.
Time frame: 18-20 hours post-ICSI
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — "Individual participant data (IPD) will not be shared due to the small sample size, the sensitive nature of reproductive and embryology data, and to protect patient confidentiality in this specialized cohort. Future larger studies may consider data sharing agreements under appropriate anonymization and ethical safeguards."
Ran from Jul 2023 to primary completion in Jul 2024, 12 months.
Of 155 interventional studies with no phase under Infertility, Female, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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