Clinical trial NCT03539874: Sperm Oxidative Stress and Pregnancy Success During IUI and IVF
Official title: Impact of Sperm Oxidative Stress on Embryonic Parameters and Pregnancy Success During Intrauterine Insemination and in Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oxidative Stress
Lead sponsor: Fertilys
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Static oxidation reduction potential
timeFrame: 1 year
measure: Reactive Oxygen Species levels
timeFrame: 1 year
Secondary outcomes:
measure: Fertilization and blastulation rates
timeFrame: 1 year
measure: Pregnancy success
timeFrame: 1 year
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Fertilys
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Marie-Claire Bélanger, PhD
role: PRINCIPAL_INVESTIGATOR
References: