Oxidative Stress and Male Infertility.

NCT06210568 | Unknown DMC

• 1 other identifier: INAIL OSES2022
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Study Aims: To evaluate the impact of oxidative and nitrosative stress, as well as DNA methylation, on male reproductive health. This is achieved by analyzing urinary biomarkers: 8-oxoGua, 8-oxoGuo, 8-oxodGuo, 3-nitrotyrosine (3-NO2Tyr), 5-methylcytidine (5-MeCyt), and cotinine in infertile and fertile males. Study Design: A prospective observational case-control study comparing infertile male patients (cases) from a reproductive sciences center with fertile male volunteers (controls) from a gynecology and obstetrics department. The study focuses on understanding the role of oxidative stress in male infertility and its implications for assisted reproductive techniques.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of oxidative and nitrosative stress, as well as DNA methylation, on male reproductive health.

  Analyze urinary biomarkers: 8-oxoGua, 8-oxoGuo, 8-oxodGuo, 3-nitrotyrosine (3-NO2Tyr), 5-methylcytidine (5-MeCyt), and cotinine in infertile and fertile males.

  2 years

Study Arms (2)

Infertile Male Patients

Other: no intervention

Fertile males

Other: no intervention

Interventions

no intervention OTHER

no intervention

Fertile males; Infertile Male Patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study includes 800 males in two groups. Group 1: 400 males from the Center for Reproductive Sciences, aged 18-50, diagnosed with infertility after over 12 months of unsuccessful conception (ART criteria, law 40/2004). Exclusions: clear infertility diagnoses (endocrinological disorders, testicular trauma, vasectomy, epididymitis, orchitis, cryptorchidism, varicocele, azoospermia), past genital radiological treatments, abnormal WHO creatinuria (0.3-3 grams). Group 2: 400 healthy males from Obstetrics and Gynecology, aged 18-50, who fathered a child naturally within 12 months. Exclusions: ART conception, over 12 months for conception, abnormal WHO creatinuria levels. This diverse population enables analyzing oxidative stress's role in male infertility, comparing infertile and fertile males' biological markers and health profiles.

You may qualify if:

• Infertile Male Patients: a diagnosis of couple infertility due to no conception for over 12 months (as per the access criteria for Assisted Reproductive Technology defined by law 40/2004), aged between 18 and 50 years, and having signed informed consent.

You may not qualify if:

• Fertile Males:conception using assisted reproductive techniques and a waiting time of more than 12 months for conception, as well as creatinuria levels outside the WHO normal range (0.3-3 grams).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Enrico Papaleo

  IRCCS San Raffaele

  STUDY DIRECTOR

• Luca Pagliardini

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Pagliardini

CONTACT

+39 02 2643 4834; pagliardini.luca@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: June 27, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)