The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments

Male Infertility Clinical Trial

Official title:

Investigating the Impact of Lifestyle on Telomere Length and Telomerase Activity on Sperm Cells Originating From Infertile Men Undergoing IVF Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04158765
• Other study ID #: 0120-18-HYMC
• Status: Recruiting
• Start date: November 20, 2019
• Est. completion date: January 2023

Study information

• Verified date: June 2022
• Source: Hillel Yaffe Medical Center
• Contact: Ofer Limonad, MD
• Phone: 972-52-5322972
• Email: oferlimonad[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This aim of this study is to determine the impact of lifestyle on telomere length and telomerase enzyme activity on sperm cells of men undergoing IVF treatments.

Description:

Following approval of the study by the Hospital Ethical Committee (Helsinki), semen samples and blood will be collected from infertile individuals referred to our IVF unit at Hillel Yaffe Medical Center. Informed written consent will be obtained from each participant. Standard semen analysis will be carried out according to World Health Organization protocol. An aliquot of semen sample will be used for assessment of sperm motility, concentration, and morphology by using computer-aided sperm analysis (CASA) and the remaining sample will be used for assessment of sperm telomere lengths and telomerase activity. Genomic DNA will be extracted from the remaining washed sperm and peripheral blood. Sperm telomere length will be determined by real-time polymerase chain reaction (qRT-PCR) and telomerase activity will be determined by TRAP assay (Telomeric Repeat Amplification Protocol).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Infertile couple

Exclusion Criteria:

• Chronic disease

• Azoospermia

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Other:
• DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).
DNA will be extracted from sperm using the DNeasy Tissue Kit and Telomerase activity in samples will be measured using a PCR- based assay.

Locations

Country	Name	City	State
Israel	Hille Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere length	After laboratory determination of telomere length, results will be compared to lifestyle of subject to see whether smoking or other lifestyle behaviors have an effect	Two years