Sperm Oxidative Stress and Pregnancy Success During IUI and IVF

Impact of Sperm Oxidative Stress on Embryonic Parameters and Pregnancy Success During Intrauterine Insemination and in Vitro Fertilization

Oxidative stress (OS) is characterized by an imbalance between the production of reactive oxygen species (ROS) and the ability of the body to eliminate them. Such an imbalance can lead to lipid peroxidation, DNA damage and cell apoptosis. Studies have suggested that infertile men are more likely to have high concentrations of ROS in their seminal plasma. The investigators hypothesize that a high level of oxidative stress (OS) in patients with abnormal sperm parameters could influence fertilization and / or pregnancy success. Our first goal is to compare OS levels to semen parameters, as defined by the World Health Organization in 2010, as well as DNA fragmentation and chromatin decondensation in sperm. Our second objective is to compare OS levels in sperm to fertilization and blastulation rates at first, and then measure the impact of OS levels on pregnancy success, both in intrauterine insemination (IUI) and in vitro fertilization (IVF). Sperm samples from men in 3 groups will be analyzed: a group of fertile men with confirmed paternity (n = 50), a group of men in IVF (n = 100) and a group of men in their first three cycles of IUI (n = 100). The static oxidation reduction index (sORP) will be measured by the MiOXSYS © system, a rapid sperm analysis system using electrochemical technology. A small portion of the fresh sperm sample will be deposited on a MiOXSYS sensor and the ORP will be measured. Sperm ROS will also be measured using the CellROX Deep Red probe. The sperm parameters will be measured by the techniques used routinely in the Fertilys Reproductive Health Center andrology lab. Regarding couples in IVF, fertilization and blastulation rates, embryo quality and pregnancy success will be noted. Pregnancy success will be noted for IUI couples. If the usefulness of sORP levels in predicting pregnancy and its outcome is demonstrated, it could be a new marker in the diagnosis of male infertility and act as a guide for clinicians to apply appropriate treatment.

Study Overview

• Status: Recruiting
• Conditions: Oxidative Stress

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Fabien Joao, M.Sc.; Phone Number: 218 4509349146; Email: fabien.joao@fertilys.org
• Study Contact Backup: Name: Cécile Adam, PhD

Study Locations

• Canada
  • Quebec
    • Laval, Quebec, Canada, H7S1Z5
      • Recruiting
      • Fertilys
      • Contact: Fabien Joao, M.Sc
      • Principal Investigator: Marie-Claire Bélanger, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18-40 in their first IUI cycle or IVF at the Fertilys Reproductive Health Center.

All men whose paternity is confirmed who come to the Fertilys Reproductive Health Center for a spermogram.

Description

Inclusion Criteria:

• All men with confirmed paternity aged 18 to 40 years, agreeing to participate in the study and having signed the consent form.
• All patients aged 18 to 40 using IVF or their first cycle of IUI at the Fertilys Reproductive Health Center, agreeing to participate in the study and having signed the consent form.

Exclusion Criteria:

• Patients under 18 and over 40 years old.
• Men who can not produce a sperm sample by anterograde ejaculation.
• Men going to the Fertilys Reproductive Health Center for a post-vasectomy spermogram.
• Couples who have already completed IUI cycles.
• Couples using gamete donation (eggs or sperm).
• Men with a mobile sperm concentration of less than 5 millions/mL after preparation of the sperm sample during the IUI process.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Confirmed paternity; Sperm sample from men with confirmed paternity
Intrauterine insemination; Sperm sample from men in intrauterine insemination process
In vitro fertilization; Sperm sample from men in in vitro fertilization process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static oxidation reduction potential	Electrical measure given by the MiOXSYS System	1 year
Reactive Oxygen Species levels	Reactive Oxygen Species levels in sperm using the CellRox Deep Red probe	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization and blastulation rates	Fertilization and blastulation rates compare to the sperm oxidative stress levels	1 year
Pregnancy success	Pregnancy outcome in IUI and IVF according to sperm oxidative stress levels	1 year

Collaborators and Investigators

• Sponsor: Fertilys
• Investigators: Principal Investigator: Marie-Claire Bélanger, PhD, Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No