Sperm Oxidative Stress and Pregnancy Success During IUI and IVF

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03539874
• Other study ID #: 2018-01
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Fertilys
• Contact: Fabien Joao, M.Sc.
• Phone: 4509349146
• Email: fabien.joao[@]fertilys.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2025
• Est. primary completion date: November 1, 2025
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oxidative Stress

Locations

Country	Name	City	State
Canada	Fertilys	Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Fertilys

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static oxidation reduction potential	Electrical measure given by the MiOXSYS System	1 year
Primary	Reactive Oxygen Species levels	Reactive Oxygen Species levels in sperm using the CellRox Deep Red probe	1 year
Secondary	Fertilization and blastulation rates	Fertilization and blastulation rates compare to the sperm oxidative stress levels	1 year
Secondary	Pregnancy success	Pregnancy outcome in IUI and IVF according to sperm oxidative stress levels	1 year