Use of Autologous Exosomes vs Platelet Growth Factors to Regenerate the Ovary in Women With Infer… (NCT06773572) | Clinical Trial Compass
CompletedNot Applicable
Use of Autologous Exosomes vs Platelet Growth Factors to Regenerate the Ovary in Women With Infertility (Exosomas2024-1)
Venezuela30 participantsStarted 2024-01-03
Plain-language summary
Ovarian stromal fibrosis resulting from each ovulation and due to aging is characterized by a decrease in hyaluronic acid concentrations, loss of synthesis and migration proteins CD63 and CD81, decreased miRNA125, miRNA21, miRNA132 and miRNA199. Also, enzymatic alterations affecting kinases and mitochondrial sirtuins SIRT3-5 with increased oxygen free radicals preventing the normal maintenance and development of folliculogenesis, leading to the inability to reproduce at advanced ages and accelerating the onset of pathologies secondary to the decrease of ovarian estrogens. Methodology: An observational, prospective, randomized, comparative, double-blind, analytical pilot study in 30 women between 38 and 46 years of age, with diminished ovarian reserve and who refused the egg donation procedure. Three groups were designated: one for autologous exosomes, one for PRP and one with physiological solution.
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:
* Female patients between 38 and 46 years of age.
* Patients with a desire to become a mother
* Patients with Body Mass Index (BMI) between 23 and 30.
* Patients with proven ovarian insufficiency, according to the parameters mentioned above.
* Patients who refuse egg donation.
* Patients with full willingness to participate in the study and who have understood and signed the informed consent.
* Patients with both ovaries without oncological pathologies, active endometriomas or suspicious ovarian or other tumors.
* Patients with platelet count over 250 thousand.
* Patients with no history of hematological diseases.
* Patients without treatment with anticoagulants.
* Patients with no active infection at the time.
Exclusion Criteria:
* Female patients outside the age range of 38 to 46 years old.
* Patients who are not willing to become mothers.
* Patients with a BMI outside the range of 23 to 30
* Patients without ovarian insufficiency
* Patients who do not wish to participate in the procedure and have not signed the informed consent form.
* Patients with suspected or diagnosed oncological diseases.
* Patients with platelet count of less than 250 thousand
* Patients with a history of hematological diseases.
* Patients with anticoagulant treatment.
* Patients with any type of active infection.
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
Primary Phase
Timeframe: Follow-up for 12 weeks for each patient.