Oxidative StressNCT03539874
Sperm Oxidative Stress and Pregnancy Success During IUI and IVF
An observational study of Oxidative Stress, run by Fertilys at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Oxidative Stress
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cécile Adam, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Fertilys
Laval, Quebec, H7S1Z5
Fabien Joao, M.Sc
Marie-Claire Bélanger, PhD
About this study
Official title: 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.
- Conditions
- Oxidative Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Static oxidation reduction potential
Electrical measure given by the MiOXSYS System
Measured: 1 year
Reactive Oxygen Species levels
Reactive Oxygen Species levels in sperm using the CellRox Deep Red probe
Measured: 1 year
Secondary outcomes (2)
Fertilization and blastulation rates
Fertilization and blastulation rates compare to the sperm oxidative stress levels
Measured: 1 year
Pregnancy success
Pregnancy outcome in IUI and IVF according to sperm oxidative stress levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertilys
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-Claire Bélanger, PhD, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539874
- Sponsor's protocol ID
- 2018-01
- Status last verified
- Jan 2024
- First submitted
- 16 May 2018
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sperm Oxidative Stress on Embryonic Parameters and Pregnancy Success During Intrauterine Insemination and in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT03539874
- Acronym / sponsor ID
- 2018-01
- Conditions
- Oxidative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- FertilysIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Static oxidation reduction potential
Time frame: 1 year
Electrical measure given by the MiOXSYS System
Reactive Oxygen Species levels
Time frame: 1 year
Reactive Oxygen Species levels in sperm using the CellRox Deep Red probe
2 secondary outcomes
Fertilization and blastulation rates
Time frame: 1 year
Pregnancy success
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Adam, PhD contact
Marie-Claire Bélanger, PhD principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress, run by Fertilys at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabien Joao, M.Sc. (4509349146 ext. 218, fabien.joao@fertilys.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static oxidation reduction potential (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.