Investigating the Effectiveness of Astaxanthin on Induced Amount of ROS in Semen and Sperm QualityAmong Patients with Varicocele through Nrf2/Keap1 Pathway
Determination the Effectiveness of Astaxanthin on Induced Amount of ROS in Semen and Sperm Quality Among Patients with Varicocele through Nrf2/Keap1 Pathway
Design
This Triple-blind randomized clinical trial, controlled by placebo, based on the guidelines contained in the Helsinki Declaration, after obtaining permission from the ethics committee of Tehran University of Medical Sciences, 50 patients will be recruited. Prior to the intervention, written informed consent will be obtained from all participants
Settings and conduct
The location of the experiment: Tehran University of Medical Sciences.
Sampling location: Royan Institute. Varicocelectomy; Collection of semen; Assessment of the expression of NRF2-Keap1 pathway genes in sperm cells; Biochemical evaluation in seminal plasma.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Varicocele II & III
• One or more Seminal characteristics lower value
• Age: older than 20
Exclusion Criteria
• Varicocele I
• Previous varicocele surgery
• Receiving a medical treatment affecting fertility for previous 3 months
• Testicular cancer and trauma
• Alcoholic, Drugs
• HIV
Investigating the Effectiveness of Astaxanthin on Induced Amount of ROS in Semen and Sperm QualityAmong Patients with Varicocele through Nrf2/Keap1 Pathway
Public title
Astaxanthin in Varicocele
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Varicocele II & III
One or more Seminal characteristics lower value
Age: older than 18
Exclusion criteria:
Varicocele I
Previous varicocele surgery
Receiving a antioxidants affecting fertility for previous 3 months
Testicular cancer and trauma
Alcoholic, Drugs
HIV
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Semen collection before and 3 months after varicocelectomy
Actual sample size reached:
43
More than 1 sample in each individual
Actual sample size in each individual:
2
Semen collection before and 3 months after varicocelectomy
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-08-13, 1401/05/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.354
Health conditions studied
1
Description of health condition studied
varicocele
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
semen parameters
Timepoint
Before and 90 days after intervention
Method of measurement
Semen analysis according to the World Health Organization (WHO) criteria
2
Description
Biochemical and inflammation factors
Timepoint
90 days after the beginning of the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
NRF2-KEAP1 pathway genes
Timepoint
90 days after the beginning of the intervention
Method of measurement
RealTime PCR
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.