An interventional study of MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system in Diminished Ovarian Reserve, sponsored by Biotech Fertility C.A.. Completed at 1 site in Venezuela. Open to female participants aged 38 Years to 48 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Biotech Fertility C.A. · Not applicable, Interventional, and Treatment
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.
Women with diminished ovarian reserve frequently present a high proportion of immature oocytes after controlled ovarian stimulation. These immature oocytes cannot be fertilized and limit the number of mature oocytes available for assisted reproductive procedures. Oocyte maturation is regulated by a coordinated set of intracellular signaling pathways, intercellular communication with granulosa cells, and molecular mechanisms that maintain meiotic arrest and trigger meiotic resumption. Emerging scientific evidence indicates that extracellular vesicles, including autologous exosomes, may play a role in supporting oocyte maturation through the transfer of bioactive molecules.
This preliminary clinical study was designed to evaluate the safety and feasibility of using autologous exosomes as a supplement to conventional in vitro maturation (IVM) media. The study population includes women aged 38-46 years with documented diminished ovarian reserve who declined oocyte donation and who met predefined clinical, endocrine, and reproductive criteria. All participants provided written informed consent. The study was conducted in accordance with national regulations and international ethical principles for research involving human subjects.
Eligible participants undergo controlled ovarian stimulation using recombinant follicle-stimulating hormone, human menopausal gonadotropin, and an antagonist protocol, followed by human chorionic gonadotropin triggering and oocyte retrieval. Only metaphase I oocytes are included in the intervention portion of the study. After identification, metaphase I oocytes are randomly assigned to one of two groups using a simple computer-generated randomization method.
In the control group, oocytes are cultured in conventional in vitro maturation medium. In the experimental group, oocytes are cultured in the same medium supplemented with a standardized quantity of autologous exosomes isolated from each participant according to the study protocol. Culture duration ranges from 24 to 36 hours. After the culture period, oocytes reaching metaphase II are fertilized via intracytoplasmic sperm injection to standardize the fertilization procedure. Embryos developing after fertilization are cultured under standardized laboratory conditions, evaluated according to established morphological criteria, and cryopreserved for use in a future phase of the research. Embryo transfer is not performed during this preliminary phase.
The primary objective of the study is to assess whether autologous exosome supplementation is feasible and safe for use in IVM culture systems. Secondary objectives include documenting the procedures involved in oocyte handling, fertilization, and embryo cryopreservation to support future phases of the study. The study does not include analysis of results or clinical outcomes, as no outcomes are permitted to be reported in the Protocol Section of the ClinicalTrials.gov record. A subsequent phase of the research will evaluate implantation, clinical pregnancy, and live birth after transfer of cryopreserved embryos generated in this protocol.
Biotech Fertility C.A. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients without a diagnosis of infertility.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
* Group I (Control): MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®). * Group II (Experimental): MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system
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 exclusively in conventional IVM medium (VITROLIFE®).
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
Proportion of Metaphase I Oocytes Reaching Metaphase II After In Vitro Cultureautologous exosomes obtained using the ExoSMarT® exosome filtration system
This measure evaluates the number and proportion of metaphase I oocytes that progress to the metaphase II stage after 24-36 hours of in vitro culture in either conventional IVM medium or IVM medium supplemented with autologous exosomes. Maturation will be identified by the presence of the first polar body. Data will be summarized as a proportion of total metaphase I oocytes cultured.
Time frame: 24-36 hours
Number of Mature Oocytes Fertilized After Intracytoplasmic Sperm Injection (ICSI)
This measure records the number and proportion of in vitro-matured metaphase II oocytes that demonstrate normal fertilization after ICSI, defined by the presence of two pronuclei under standard embryology laboratory criteria.
Time frame: Approximately 18 hours after ICSI
Plan to share: No — Not but the individual participant data (IPD) from this study will be available to other qualified researchers upon reasonable request. Data sharing will be granted after a formal email request specifying the investigator's identity, institutional affiliation, and research objective. Access will be provided only for scientifically justified purposes, in compliance with confidentiality agreements and ethical standards protecting participant privacy.
Ran from Jan 2023 to primary completion in Jan 2025, 24 months.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Biotech Fertility C.A.