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Sperm Oxidative Stress and Pregnancy Success During IUI and IVF

Sponsor
Fertilys (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03539874
Collaborator
(none)
250
Enrollment
1
Location
52.8
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Sperm Oxidative Stress on Embryonic Parameters and Pregnancy Success During Intrauterine Insemination and in Vitro Fertilization
    Actual Study Start Date :
    Jan 7, 2019
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Static oxidation reduction potential [1 year]

      Electrical measure given by the MiOXSYS System

    2. Reactive Oxygen Species levels [1 year]

      Reactive Oxygen Species levels in sperm using the CellRox Deep Red probe

    Secondary Outcome Measures

    1. Fertilization and blastulation rates [1 year]

      Fertilization and blastulation rates compare to the sperm oxidative stress levels

    2. Pregnancy success [1 year]

      Pregnancy outcome in IUI and IVF according to sperm oxidative stress levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fertilys Laval Quebec Canada H7S1Z5

    Sponsors and Collaborators

    • Fertilys

    Investigators

    • Principal Investigator: Marie-Claire Bélanger, PhD, Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fertilys
    ClinicalTrials.gov Identifier:
    NCT03539874
    Other Study ID Numbers:
    • 2018-01
    First Posted:
    May 29, 2018
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 19, 2021