Status:
NOT_YET_RECRUITING
The Impact of Probiotics on Sperm Quality in Middle-aged Men
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Sperm Quality
Eligibility:
MALE
40-59 years
Phase:
NA
Brief Summary
The clinical trial aims to investigate the impact of probiotic strain BL21 on sperm quality among 46 middle-aged male participants. The primary objective is to validate whether probiotic strain BL21 c...
Detailed Description
Research has indicated that an increase in male age is independently associated with a reduction in the percentage of motile sperm and sperm with normal morphology, especially in men over 40 years old...
Eligibility Criteria
Inclusion
- Subjects aged 40-59 years old.
- Normal levels of gonadotropins, testosterone, and serum prolactin.
- No use of other traditional Chinese and Western medicines for oligoasthenoteratozoospermia treatment in the past 3 months.
- Patients who can understand the clinical study and commit to complying with the study requirements and procedures.
- Patients who have signed the informed consent form and are able to complete the study as per the trial protocol.
Exclusion
- Organic lesions of the reproductive system;
- Use of antibiotics in the two weeks prior to recruitment;
- Sexual dysfunctions such as erectile dysfunction, ejaculatory abnormalities, preventing completion of sexual intercourse;
- Genitourinary infections, such as Chlamydia or Mycoplasma infections;
- Abnormal sex hormone levels;
- Obesity (BMI greater than 28);
- History of allergies to the probiotic preparations used in this study;
- Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, hematologic disorders, psychiatric illnesses, or other severe comorbidities;
- Use of medications in the past 3 months that may affect the trial;
- According to the investigator's judgment, the subject's condition does not qualify them for participation in the study.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06544278
Start Date
August 30 2024
End Date
June 1 2025
Last Update
August 9 2024
Active Locations (1)
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1
Qilu Hospital of Shangdong University
Jinan, Shangdong, China, 250012