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IRCT20230924059501N1 IRCT 2023-11-06 Tehran University of Medical Sciences Astaxanthin in Varicocele Investigating the Effectiveness of Astaxanthin on Induced Amount of ROS in Semen and Sperm QualityAmong Patients with Varicocele through Nrf2/Keap1 Pathway 2022-05-25 anticipated 50 Complete https://irct.ir/trial/72848 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be randomly assigned to the study after visiting the gynecology clinic. Randomization will be in the form of blocking in such a way that the method of replacement blocks is used within each floor. The blocks will be binary, consisting of AB and BA. The randomization tool will be a table of random numbers, that using the sequence AB for numbers zero through 4 in the random number table and the sequence BA for 5 to 9.It should be noted that the letter A means the intervention group and the letter B means the control group For hiding we use concealment allocation in a way that before the individual is assigned, the assigned group is not specified. In this method, each of the random sequences created on a cards are placed in the closed envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the time of registration of participants, based on the order of entry of the eligible participants in the study, one of the closed envelopes will be opened and the assigned group of the participant will be revealed, Blinding description: This study will be a three-way blind and the patient, researcher and statistical analyst of the patients' group therapy have no information and the decoder is outside the research team. The drug under study (Astaxanthin) and placebo in a completely similar shape and appearance, each of which is 60 in the same bottle instead of the drug will be provided to the subjects based on random allocation. It should be noted that the drug content of each The bottles are code-tagged on the bottles by the by someone outside the research team consultant and the research team is not aware of their interpretation. 3 varicocele. Intervention 1: Intervention group: Astaxanthin consumption. In this group, patients take 6 mg of astaxanthin (1 capsule/day) for 90 days. Their routine treatment does not stop. Intervention 2: Control group: Placebo consumption. In this group, patients take 6 mg of placebo (1 capsule/day) for 90 days. Their routine treatment does not stop. Yes - There is a plan to make this available What will be shared: All data obtained in the research will be published in one of the valid and related scientific journals. When: Spring 2024 To whom: Researchers working in academic institutions Conditions: The data of this study can be used as an adjuvant therapy in patients with Varicocele. Where to obtain: Shimal Mohammed Salih How to obtain: By sending an email to the corresponding author. Comments:
public Dr. Fardin Amidi
Poursina St. School of Medicine, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3411 amidifardin@yahoo.com Tehran University of Medical Sciences scientific Shimal Mohammed Salih
Poursina St. School of Medicine, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3411 shimalayub@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Varicocele II & III One or more Seminal characteristics lower value Age: older than 18 18 years 45 years Male Varicocele I Previous varicocele surgery Receiving a antioxidants affecting fertility for previous 3 months Testicular cancer and trauma Alcoholic, Drugs HIV I86.1 Scrotal varices Treatment - Drugs Placebo Intervention group: Astaxanthin consumption. In this group, patients take 6 mg of astaxanthin (1 capsule/day) for 90 days. Their routine treatment does not stop. Control group: Placebo consumption. In this group, patients take 6 mg of placebo (1 capsule/day) for 90 days. Their routine treatment does not stop. Semen parameters. Timepoint: Before and 90 days after intervention. Method of measurement: Semen analysis according to the World Health Organization (WHO) criteria. Biochemical and inflammation factors. Timepoint: 90 days after the beginning of the intervention. Method of measurement: ELISA. NRF2-KEAP1 pathway genes. Timepoint: 90 days after the beginning of the intervention. Method of measurement: RealTime PCR. Tehran University of Medical Sciences Approved 2022-08-13 Ethics committee of Tehran University of Medical Sciences Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St Tehran Tehran Iran (Islamic Republic of)