Status:
COMPLETED
Effects of Lifestyle Changes on Semen Quality in Healthy Young Men Living in Highly Polluted Areas (FAST)
Lead Sponsor:
Azienda Sanitaria Locale Salerno
Collaborating Sponsors:
Istituto clinico Città di Brescia
Università degli Studi di Brescia
Conditions:
Fertility Disorders
Eligibility:
MALE
18-22 years
Phase:
NA
Brief Summary
We planned a randomized controlled trial (RCT) with the main aim to evaluate the effects of lifestyle changes on semen quality in healthy young men living in polluted areas in Italy. Secondary aims ar...
Detailed Description
Human semen quality is affected by genetic, metabolic, lifestyle and environmental factors. It is a sensitive marker of the general health status of an individual and a predictor of disease occurrence...
Eligibility Criteria
Inclusion
- Young healthy men aged 18-22 years, who have been living at least for 5 years in one of the recruitment areas (Lombardy Region, "Land of fires" or Valley of the Sacco river)
- Normal weight (18,5 ≤ Body Mass Index \< 25)
- Waist circumference \< 102cm
- Having a normal sperm count (not azoospermic or cryptospermic)
- Drinking less than 5 alcohol units a week (1AU=125ml)
- Smoking less than 5 cigarettes (including e-cigarette, cigar, pipe)
- Smoking marijuana less than 3 times a month
- Must not have undergone urogenital surgery.
- Must not have suffered cancer disease and/or undergone chemo/radiotherapy.
Exclusion
- Smoking more than 5 cigarettes a week
- Smoking marijuana more than 3 times a month
- Using drugs (other than marijuana)
- Drinking more than 5 alcohol units a week (1AU=125ml)
- Using dietary supplements (any type)
- Having a prior urogenital surgery (for varicocele: up to 12 months before the enrollment)
- Having suffered cancer and/or undergone chemo/radiotherapy
- Using anti-inflammatory drug on a regular basis (such as cortisone and/or NSAIDs) and/or having taken one of those drugs up to 72 hours before the collection of blood and semen samples.
- Using phosphodiesterase type 5 inhibitors (PDE5 inhibitor) up to 72 hours before the collection of blood and semen samples.
- Using steroids and/or anabolic hormones.
- Using dietary supplements and/or substances containing vegetal/animal extracts and/or trace elements up to 6 months before the enrollment.
- Fever status and/or antibiotic therapy up to 2 weeks before the enrollment.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2019
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT04012385
Start Date
May 2 2018
End Date
November 6 2019
Last Update
January 9 2020
Active Locations (4)
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1
Urology Unit "S. Francesco d'Assisi" Hospital
Oliveto Citra, Salerno, Italy, 84020
2
Unit of Hygiene, Epidemiology and Public Health, University of Brescia
Brescia, Italy, 25123
3
Unit of Urology - Istituto Clinico Città di Brescia
Brescia, Italy, 25128
4
Dpt. of Food safety, nutrition and veterinary public health, Italian National Institute of Health (ISS)
Roma, Italy, 00161