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IRCT20240222061085N1 IRCT 2024-03-04 Zahedan University of Medical Sciences The effect of HCG therapy on the amount of sperm extraction in men with non-obstructive azoospermia hcg The effect of HCG therapy on the amount of sperm extraction in men with non-obstructive azoospermia 2024-03-19 anticipated 64 Complete https://irct.ir/trial/75711 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: *Allocation concealment is done using 'coincidence sequence sealed opaque envelopes'. In this way, the random sequence is determined first, then the sequences are recorded on a card and the cards are placed in the envelopes in order. The outer surface of the envelopes is numbered and placed in the box in order. Participants will choose an envelope in order of entry and the intervention group will be determined, Blinding description: *Blinding: it is double-blind, the patient is not aware of the type of intervention performed, and on the other hand, the doctor evaluating the outcome of the study is also not aware of the type of treatment used. 1-2 Infertility. Intervention 1: Intervention group: In patients who meet the study entry criteria, HCG will be prescribed as 5000 IU subcutaneous injection twice a week for 10 to 14 weeks. After the end of the HCG therapy period, sperm analysis will be taken from the patient's semen and the number of motile sperm as well as the serum level of LH, FSH, testosterone and prolactin will be checked and recorded. If in the Semen sample after HCG therapy, the patient still has azoospermia, he will be subjected to TESE for sperm extraction. In all stages of testing and sampling, patient information will remain confidential and ethical codes of research on human samples will be observed. Intervention 2: Control group: This group includes patients who are azoospermic and did not consent to receiving the HCG drug. This group will not receive drug treatment and will be followed periodically like the control group. Yes - There is a plan to make this available What will be shared: Data from infertile people receiving hcg When: The access period starts 1 month after the results are published To whom: Scientific researchers Conditions: The use of data in pregnancy research is not prohibited. Where to obtain: Ali Bin Abi Talib (AS) Hospital - Research Center - Dr. Abdol-Rahman Kalkali How to obtain: After registering the research title in the field of fertility, it will be possible to access the data. Comments:
public AbdolRahman Kalkali
Zibashar, Pirozi 4
Zahedan Iran (Islamic Republic of) 9817911905 +98 915 285 7422 Abdikalkali@gmail.com Zahedan University of Medical Sciences scientific Abdol-rahman Kalkali
Baharan complex, Payambar ahzam, Zibashar
Zahedan Iran (Islamic Republic of) 9817911905 +98 915 285 7422 abdikalkali@Gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Male patients with infertility caused by non-obstructive azoospermia at least twice Semen Analysis 20 years 60 years Male They received exogenous testosterone receive chemotherapy or radiotherapy at the time of study Unilateral or bilateral non-palpable testicles and Increased serum prolactin. Confirmed chromosomal abnormalities N46 Male infertility Treatment - Drugs Treatment - Other Intervention group: In patients who meet the study entry criteria, HCG will be prescribed as 5000 IU subcutaneous injection twice a week for 10 to 14 weeks. After the end of the HCG therapy period, sperm analysis will be taken from the patient's semen and the number of motile sperm as well as the serum level of LH, FSH, testosterone and prolactin will be checked and recorded. If in the Semen sample after HCG therapy, the patient still has azoospermia, he will be subjected to TESE for sperm extraction. In all stages of testing and sampling, patient information will remain confidential and ethical codes of research on human samples will be observed. Control group: This group includes patients who are azoospermic and did not consent to receiving the HCG drug. This group will not receive drug treatment and will be followed periodically like the control group. The rate of sperm extraction in men with non-obstructive azoospermia. Timepoint: 3 months after receiving hcg. Method of measurement: Sperm analysis. Zahedan University of Medical Sciences Approved 2024-01-29 Ethics committee of Zahedan University of Medical Sciences Persian Gulf Blvd., Dr. Hasabi Square, Zahedan Medical Sciences Campus Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)