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IRCT20230528058312N2 IRCT 2024-02-07 Research assistant for infertility treatment andTahoora limited surgery clinic Exosome and stem cells therapy Investigating the effect of exosome injection extracted from seminal plasma, stem cells derived from Wharton's testosterone gel and FSH on the process of spermatogenesis in NOA individuals. 2024-02-20 anticipated 50 Complete https://irct.ir/trial/75210 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 1 Non-obstructive azoospermia. Intervention 1: Intervention group: This group receives only 50 microliters of exosomes extracted from the semen of healthy people. Semen samples are collected in the Andrology Laboratory of Tahura Infertility Clinic from patients who come for semen analysis, and then normal samples that count more than 25 *106, morphology above 4%, motility above 50%, which is more than 40% progressive movement and finally their DFA is less than 15% are isolated. It should be noted that samples taken from people are examined for HIV, HCV and HPV health. and if the tests are negative, after collecting the samples, Polyethylene glycol (PEG (6000 kDa) will be prepared with a concentration of 500 mg/ml along with sterile PBS (pH 7.4) to extract the exosome. Then 50 µl of PEG and PBS solution with the mentioned concentration with 250 µl of cement liquid that passes through the 0.22 filter, finally after incubation of the mentioned mixture for 12 hours at 4 °C, with a rotation of 3000 rpm for 30 minutes They will be centrifuged at a temperature of 4°C. The supernatant is discarded and the plate is used to check the presence of exosomes with a nanodrop spectrophotometer, the protein concentration of DNA and RNA is then checked with an electron microscope for the presence of exosomes. In addition, CD9, CD 63, CD81, CD82 It will be checked. Finally, 50 microliters of the extracted exosome will be injected into the testicles of non-obstructed azoospermia individuals with an insulin syringe. Intervention 2: Intervention group:This group will receive stem cells extracted from Wharton's gel. Stem cells will be prepared from 7 umbilical cord samples from the private cord blood bank. Umbilical cord donors are healthy mothers, free of genetic and underlying diseases and based on serology tests and free of viral diseases (syphilis, HTLV I/II, HBV, HCV, HIV, and CMV) will be collected during delivery and in sterile PBS containing Penicillin and streptomycin antibiotics will be sent to the umbilical cord stem cell extraction laboratory for stem cell extraction. Finally, vials with a concentration of 10 x 107 cells will be delivered. And a concentration of 5 x 107 cells is injected into each testicle. Intervention 3: Intervention group: Participants in this group will be given 10 micromoles of testosterone and 500IU/L of FSH hormone, and after 3 month we will check the differentiation of germ cells with the help of pathology test. Yes - There is a plan to make this available What will be shared: All data obtained after identification of study cases can be shared. When: All information is accessible in April 2025 To whom: Our data will be available for all researchers and Doctors Conditions: All information related to the performed ultrasounds, tests related to exosome and stem cell extraction will be accessible Where to obtain: Applicants can contact one of the following email addresses to receive documents or data: asalighe@yahoo.com taba_1359@yahoo.com How to obtain: Three weeks after sending the applicant's message, the requested documents and files will be sent. Comments:
public seyed Reza Tabatabaee Qomi
Tahoora infertility treatment and lmited surgury clinic,Tahoora street,Jamkaran
Ghoum Iran (Islamic Republic of) 3747113135 3747113135 taba_1359@yahoo.com Tahoora infertility treatment and lmited surgury clinic scientific Dr.seyed Reza Tabatabaee Qomi
Tahoora infertility treatment and lmited surgury clinic,Tahoora street,Jamkaran
Ghoum Iran (Islamic Republic of) 3747113135 +98 25 3725 4719 taba_1359@yahoo.com Tahoora infertility treatment and lmited surgury clinic Iran (Islamic Republic of) People who do not have sperm in their semen samples (Azoospermia) will be selected. In order to exosome extraction from seminal plasma, people who have normal semen samples (according to global standards (WHO)) will be selected. no limit no limit Male People with obstructive azoospermia Azoospermia whose testicular tissue biopsy did not show germ cells N46 Male infertility Treatment - Other Treatment - Other Treatment - Other Intervention group: This group receives only 50 microliters of exosomes extracted from the semen of healthy people. Semen samples are collected in the Andrology Laboratory of Tahura Infertility Clinic from patients who come for semen analysis, and then normal samples that count more than 25 *106, morphology above 4%, motility above 50%, which is more than 40% progressive movement and finally their DFA is less than 15% are isolated. It should be noted that samples taken from people are examined for HIV, HCV and HPV health. and if the tests are negative, after collecting the samples, Polyethylene glycol (PEG (6000 kDa) will be prepared with a concentration of 500 mg/ml along with sterile PBS (pH 7.4) to extract the exosome. Then 50 µl of PEG and PBS solution with the mentioned concentration with 250 µl of cement liquid that passes through the 0.22 filter, finally after incubation of the mentioned mixture for 12 hours at 4 °C, with a rotation of 3000 rpm for 30 minutes They will be centrifuged at a temperature of 4°C. The supernatant is discarded and the plate is used to check the presence of exosomes with a nanodrop spectrophotometer, the protein concentration of DNA and RNA is then checked with an electron microscope for the presence of exosomes. In addition, CD9, CD 63, CD81, CD82 It will be checked. Finally, 50 microliters of the extracted exosome will be injected into the testicles of non-obstructed azoospermia individuals with an insulin syringe. Intervention group:This group will receive stem cells extracted from Wharton's gel. Stem cells will be prepared from 7 umbilical cord samples from the private cord blood bank. Umbilical cord donors are healthy mothers, free of genetic and underlying diseases and based on serology tests and free of viral diseases (syphilis, HTLV I/II, HBV, HCV, HIV, and CMV) will be collected during delivery and in sterile PBS containing Penicillin and streptomycin antibiotics will be sent to the umbilical cord stem cell extraction laboratory for stem cell extraction. Finally, vials with a concentration of 10 x 107 cells will be delivered. And a concentration of 5 x 107 cells is injected into each testicle. Intervention group: Participants in this group will be given 10 micromoles of testosterone and 500IU/L of FSH hormone, and after 3 month we will check the differentiation of germ cells with the help of pathology test. Absence of sperm, observation of germ cells in testicular tissue pathology. Timepoint: 3 months after the injection of stem cells, exosome, FSH, testosterone. Method of measurement: Siemens analysis, TESE surgery. Research assistant for infertility treatment andTahoora limited surgery clinic Approved 2023-11-27 Islamic Azad University - Qom Branch (Research Ethics Committee) Shahzad Seyed Ali St., Islamic Azad University, Qom branch Ghoum Ghoum Iran (Islamic Republic of)