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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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26 October 2020 |
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Main ID: |
ISRCTN22596524 |
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Date of registration:
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21/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of transient scrotal hyperthermia on spermatogenesis
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Scientific title:
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Effect of transient scrotal hyperthermia on spermatogenesis |
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Date of first enrolment:
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01/05/2013 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN22596524 |
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Study type:
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Interventional |
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Study design:
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Single-center interventional randomised controlled trial (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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China
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Changhong
Zhu |
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Address:
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No.13, Hangkong Road
430030
Wuhan
China |
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Telephone:
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+86 (0)27 8369 2651 |
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Email:
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rm3816205@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Male
2. 22–50 years old
3. Married and having fathered at least one child
4. No plan to father another child
5. Good health without hypertension or trauma
Exclusion criteria:
1. Not married or have no children
2. Plan to have another child
3. Cryptorchidism or varicocele
4. Severe heart, brain or renal disease
5. Could not commit to finishing the experiment
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Spermatogenesis
Not Applicable
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Intervention(s)
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Subjects were initially randomized into one of the two groups, each group consisting of 10 volunteers. All of the subjects underwent testicular warming at 43°C in a water bath 10 times, for 30 min each time. In brief, the lower half body of each subject was soaked in the bathtub in which the water was regulated to be 43°C. To maintain the water temperature constant, we continuously added the adjusted hot water (43°C) into the bathtub, and we also drained the water from the bathtub by the same flow rate. For subjects in Group 1, this was carried out once a day for 10 consecutive days while for subjects in Group 2, it was once every 3 days, 10 times. The treatment phase was followed by a recovery phase of 16 weeks.
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Primary Outcome(s)
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Semen samples were collected twice before treatment and at week 2, 4, 6, 8, 10, 12, 14 and 16 after treatment. The samples were obtained from each subject by masturbation after between 3 and 7 days of sexual abstinence.
1. Sperm concentration, sperm motility and total sperm count were observed under a microscope.
2. Total acrosin activity was measured using a commercially available kit (HuaKang, Shenzhen, China).
3. Seminal plasma biochemical markers including semen plasma fructose, zinc and neutral alpha glucosidase, were all tested by using enzymic and spectrophotometric methods.
4. Semen plasma oxidative stress was evaluated by the markers of superoxide dismutase (SOD), catalase (CAT) activity and malondialdehyde (MDA), these markers were all tested by using a spectrophotometric method.
Venous blood samples were collected before treatment and at week 3, 6, 9, 12, 15 after treatment, 4 ml for each time. Blood samples were used for reproductive hormone assays, including follicle stimulating hormone (FSH), luteinizing hormone (LH), sex hormone binding globulin (SHBG), estradiol (E2), testosterone and free testosterone. All these hormones were tested using a chemiluminescent immunoassay method on the automated UniCel DxI 800 analyzer.
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Secondary Outcome(s)
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Semen samples were collected twice before treatment and at week 2, 4, 6, 8, 10, 12, 14 and 16 after treatment. The samples were obtained from each subject by masturbation after between 3 and 7 days of sexual abstinence.
1. Sperm DNA integrity was detected using flow cytometry
2. Sperm apoptosis was evaluated using mitochondrial membrane potential commercial assay kit and TdT-mediated dUTP nick-end labeling (TUNEL) assay kit
3. Sperm protein levels were analyzed by using a western blotting method.
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Source(s) of Monetary Support
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Ministry of Science and Technology of the People's Republic of China
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology, 28/11/2012, No. 20130311
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/08/2015 |
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URL:
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