Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06210568 |
| Other study ID # |
INAIL OSES2022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 27, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
IRCCS San Raffaele |
| Contact |
Luca Pagliardini |
| Phone |
+39 02 2643 4834 |
| Email |
pagliardini.luca[@]hsr.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Infertility affects approximately 15% of couples in their reproductive age. Male factors
contribute to 45-50% of infertility cases, with 7% of the global male population diagnosed as
infertile. Oxidative stress, defined as an imbalance between reactive oxygen species (ROS)
and antioxidants, plays a significant role in semen quality degradation. High levels of ROS,
unbalanced by antioxidant mechanisms, damage spermatozoa, affecting motility and morphology,
and compromising their fertilizing ability. Excessive ROS production, antioxidant depletion,
and inactivation or reduced production of antioxidant enzymes contribute to this imbalance.
Oxidative stress not only induces lipid peroxidation in sperm membranes but also impacts DNA
integrity and increases apoptosis rates. It is estimated to be a significant factor in 30-80%
of male infertility cases. Oxidative and nitrosative stress are interrelated; increased ROS
levels can interact with nitrogen species, causing further reproductive function damage.
Urinary oxidized nucleic acid bases, particularly 8-oxo-7,8-dihydroguanine (8-oxoGua) and
8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodGuo), serve as biomarkers of oxidative stress.
Additionally, DNA methylation plays a crucial role in biological processes, with
5-methylcytidine (5-MeCyt) acting as an epigenetic biomarker.
Objectives:
The primary objective is to assess the role of oxidative, nitrosative stress, and DNA
methylation on male reproductive health by evaluating urinary biomarkers: 8-oxoGua, 8-oxoGuo,
8-oxodGuo, 3-nitrotyrosine (3-NO2Tyr), 5-MeCyt, and cotinine. The secondary objectives
include evaluating semen quality parameters impacted by oxidative stress and identifying
potential environmental and lifestyle exposure sources contributing to oxidative stress.
Study Design:
This monocentric, prospective observational study will involve two patient groups: infertile
male patients ("cases") attending the Center for Reproductive Sciences and fertile male
volunteers ("controls") from the Department of Gynecology and Obstetrics. Procedures for
patients and volunteers are additional to the study protocol and not experimental in nature.
The study aims to provide a comprehensive understanding of oxidative stress in male
infertility and its potential impact on assisted reproductive techniques.
