In Vitro Oocyte Maturation With Autologous Exosomes in Women (NCT07249411) | Clinical Trial Compass
CompletedNot Applicable
In Vitro Oocyte Maturation With Autologous Exosomes in Women
Venezuela32 participantsStarted 2023-01-02
Plain-language 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.
Who can participate
Age range
38 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with primary or secondary infertility associated with diminished ovarian reserve, defined by ultrasound findings and laboratory parameters (FSH \> 10 mIU/mL and estradiol \< 60 pg/mL).
* Serum anti-Müllerian hormone (AMH) concentration \< 1 ng/mL.
* Antral follicle count \< 3-6 follicles per ovary.
* Anatomical preservation of both ovaries.
* Body mass index (BMI) between 24.5 and 30 kg/m².
* Absence of active oncological pathologies or connective tissue diseases (collagenopathies).
* No history of clinically relevant hematological disorders.
* Adequate serum levels of vitamins essential for reproductive function, including vitamin D, B-complex, and vitamin C.
* Last live birth within ≤ 10 years prior to study initiation.
* Normal thyroid function (TSH and free thyroid hormones within range).
* Absence of antiphospholipid antibody syndrome.
* Male partner with semen parameters within normal limits, according to the World Health Organization (WHO) criteria, 2010 (5th edition) and 2021 (6th edition).
* Signed informed consent for participation in the study.
Exclusion Criteria:
* • Patients without a diagnosis of infertility.
* Women without documented diminished ovarian reserve.
* Serum anti-Müllerian hormone (AMH) concentration \> 1 ng/mL.
* Antral follicle count \> 3-6 follicles per ovary.
* Absence of one or both ovaries.
* Body mass index (BMI) \> 30 kg/m².
* Presence of active oncological pathologies or connective tissue diseases…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Metaphase I Oocytes Reaching Metaphase II After In Vitro Cultureautologous exosomes obtained using the ExoSMarT® exosome filtration system
Timeframe: 24-36 hours
2
Number of Mature Oocytes Fertilized After Intracytoplasmic Sperm Injection (ICSI)