Sperm Oxidative Stress and Pregnancy Success During IUI and IVF

NCT03539874 | Unknown

• 1 other identifier: 2018-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fertilization and blastulation rates

  1 year

• Pregnancy success

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fertilys: lead

Study Sites (1)

Fertilys

Laval, Quebec, H7S1Z5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sperm sample

Study Officials

• Marie-Claire Bélanger, PhD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien Joao, M.Sc.

CONTACT

4509349146; fabien.joao@fertilys.org

Cécile Adam, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 30, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CA (1)