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IRCT20171031037132N2 IRCT 2019-03-11 Mashhad University of Medical Sciences Comparison of the effect of Iranian medicine based on spider and acupuncture on sperm parameters, some inflammatory factors and sex hormones in men with idiopathic infertility: a randomized, one-way clinical trial Comparison of the effect of Iranian medicine based on spider and acupuncture on sperm parameters, some inflammatory factors and sex hormones in men with idiopathic infertility: a randomized, one-way clinical trial 2019-04-04 anticipated 51 Complete https://irct.ir/trial/37527 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment will be done using the PASS software, and the individuals will be assigned in the assigned groups according to their order of entry. The envelopes are prepared by a research team member and, with the help of random numbers, arrange the arrival of individuals into groups, which will be packaged with the help of the PASS software and will be printed inside the envelope. Pocket doors will be closed and its contents are not visible from the outside, Blinding description: In this study, the patient is not blind to his treatment method in relation to his group, this situation is true for the main investigator and therapists, but data collection and follow-up officials have been blinded to study groups. 3 Male infertility. Intervention 1: Control group: Two tablets of 400 mg of pentoxifylline ( Manufactured by Hakim Pharmaceutical Company. Tehran-Iran) will be taken daily for three months each day. Intervention 2: Intervention group1: Patients receive three 800 mg capsules (including Ceratonia siliqua, Cinnamomum verum and Tribulus terrestris) for three months each day. Intervention 3: Intervention group2: Patients undergo acupuncture for 16 sessions over a three month period.The first week of the week is 2 sessions, the next 2 months are weekly 1 session and a total of 16 sessions. Acupuncture points include:CV4, CV2, BL23, BL52, KI 3, KI 6, KI 7, SP6, SP9, LI 4, LI 11, LV3, ST28, ST 30 . And the Ren 2 and Ren 4 points are connected to the electro-acupuncture device. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It will be determined after the start of the study
public Hamidreza Bahrami Taghanaki
End of Sanabad Street, Deputy of Health of Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9185684538 +98 51 3841 5001 BahramiHR@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Ahmadian
Azadi Square, Campus University,Faculty of Iranian and Complementary Medicine
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8931 Ahmadianm1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to cooperate Passing for at least one year from the time you decide to give birth and not use contraceptives Men aged 20-45 Concerning the decline in sperm motility with unknown cause based on WHO criteria (less than 50% sperm motility) Normal levels of gonadotropins, testosterone and serum prolactin 20 years 45 years Male Infection of the genital system anatomical abnormalities in the genital system such as varicocele from the operation and not, cryptorchidism and ... systemic diseases or drug treatments in the last three months History of surgical procedures on the testes and vas deferens Patients with ICSI candidate due to severe spermogram disorder and presence of other infertility factors Contact with pesticides, heavy metals and solvents; use of antioxidant supplement in the last three months Coagulation disorders, infection, eczema at the site of needle and phobia from the needle N46 Male infertility Treatment - Drugs Treatment - Drugs Treatment - Devices Control group: Two tablets of 400 mg of pentoxifylline ( Manufactured by Hakim Pharmaceutical Company. Tehran-Iran) will be taken daily for three months each day Intervention group1: Patients receive three 800 mg capsules (including Ceratonia siliqua, Cinnamomum verum and Tribulus terrestris) for three months each day. Intervention group2: Patients undergo acupuncture for 16 sessions over a three month period.The first week of the week is 2 sessions, the next 2 months are weekly 1 session and a total of 16 sessions. Acupuncture points include:CV4, CV2, BL23, BL52, KI 3, KI 6, KI 7, SP6, SP9, LI 4, LI 11, LV3, ST28, ST 30 . And the Ren 2 and Ren 4 points are connected to the electro-acupuncture device. Sperm motility. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Spermogram. Sperm count. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Spermogram. Sperm morphology. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Spermogram. Prolactin hormone. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Elisa Reader. Testosterone hormone. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Elisa Reader. Luteinizing hormone. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Elisa Reader. Follicle stimulating hormone. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Elisa Reader. Malondialdehyde. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Elisa Reader. C-Reactive Protein. Timepoint: Before the start of the study and three months after the start of the intervention. Method of measurement: Elisa Reader. Mashhad University of Medical Sciences Approved 2019-01-26 The Ethics Committee of Mashhad University of Medical Sciences Mashhad Univercity Of Medical Sciences, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)