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Male Infertility clinical trials

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NCT ID: NCT04585984 Recruiting - Male Infertility Clinical Trials

Effect of Antioxidant Probiotic Administration on Seminal Quality and Reproductive Outcomes.

Start date: February 5, 2021
Phase: N/A
Study type: Interventional

The quality of semen plays a fundamental role in correct fertilization and development of normal embryos that result in a live birth. Unfortunately, semen quality has declined during the last decades, and reduced more and more. The cases of male factor infertility currently correspond to 30% of the reported cases of infertility. The parameters that are directly affected in infertile men reflecting an impaired spermatogenesis are sperm concentration, motility, morphology, ejaculate volume and DNA damage, in addition to various alterations at the molecular level that often go unnoticed and are related to the physiological capacity of the sperm. These alterations result in a decrease in reproductive capacity, which leads to the need for assisted reproduction techniques (ART). The identification of new ways to increase the quality of sperm could be very useful to improve the reproductive performance of patients. Probiotics are defined as 'living microorganisms, which, when administered in adequate amounts, confer benefits for the health of the host'. The consumption of probiotics is increasing worldwide as therapy for many different diseases and disorders. In the field of assisted reproduction, the microbiome has been extensively studied with respect to the female endometrium to assess endometrial receptivity. However, there is little evidence about the role of the microbiome in semen. Previous studies demonstrated a moderate improvement on some sperm parameters, but still there is a need to confirm its translation into a clinical contribution to reproductive success. The aim of this study is to evaluate the effect of these strains, Lactobacillus rhamnosus CECT8361 and Bifidobacterium longum CECT7347, on the seminal quality of infertile patients coming to IVIRMA clinics to undergo their first IVF/ICSI cycle by means of determining direct improvement on the basic sperm analysis results, on sperm DNA integrity and on the seminal microbiome profile, to ultimately evaluate the effect that it may have on the embryo quality and reproductive results of the cycles of these patients.

NCT ID: NCT04541459 Recruiting - Male Infertility Clinical Trials

Validation of New Devices Against Ambient Electromagnetic Radiation

Start date: September 14, 2020
Phase: Early Phase 1
Study type: Interventional

Project Summary Cell phones have become indispensable devices in the investigator's daily life. These phones operate between 400 and 2000 MHz frequency bands and emit radiofrequency electromagnetic waves (EMW). Radio-frequency electro-magnetic field exposure from cell phones or other sources of microwaves have deleterious effects on sperm parameters (like sperm count, morphology, motility). Further, EMW radiation emitted by mobile phones affects cells and organelles, and results in disorientation of charged molecules within the cytosol and a distortion of electron flow along the internal membranes of the cells. These cellular changes results in the generation of ROS leading to oxidative stress, which in turn results in radiation-induced sperm DNA fragmentation. Radiation shield can help provide protection from high levels of EMW radiations deflecting, diverting, and absorbing the radiation between the user and the source. A new EMW radiation shield, Qi-Shield device developed by Waveguard GmbH (Bautzen, Germany) provides protection against the radiations emitted by the smartphone and laptop devices. Qi-Shield utilizes conductive fluids in a particular geometric arrangement intended to ameliorate the negative effects of EMW radiation. Study Aims: To evaluate the changes in the semen parameters from the use of Qi-Shield device in sham (control) and user groups To determine the molecular changes pertaining to sperm proteins from the use of Qi-Shield device in sham (control) and user groups Significance The negative health consequences of EMWs have been documented across a wide range of device types, exposure frequencies and doses (Giuliani, 2010), at field strengths substantially below the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for permissible exposures. In the absence of a revision in the ICNIRP guidelines, near-term public exposures to EMWs will most certainly continue to increase, despite the scientific evidence suggesting more careful review and recommendations to limit exposure to electromagnetic fields as much as possible. At present, there is no veritable means for counteracting the negative health consequences of human-made EMWs, revealing an unmet need for a means of protecting from or ameliorating the negative effects of EMWs, and the need for devising strategies for creating safer living and working environments in a time of increasing EMW exposures. Positive results in this study would demonstrate a means of counteracting negative effects on human sperm due to EMWs. Documentation of protection due to the Qi-Shield devices would show proof of principle that a low-cost passive device, portable and without battery or mains power, can provide improvements in human sperm parameters, with promise for a means of counteracting EMW-reduced fertility in large numbers of people. Confirmation of changes on protein expression would provide data needed to identify specific pathways of action, insight that is necessary for a more detailed understanding of the mechanisms of action of the EMW protection effect. Taken together, these results would suggest further lines of study in EMW protection, and provide clinical support for the adoption of EMW-protecting devices in the home and workplace.

NCT ID: NCT04200118 Recruiting - Cancer Clinical Trials

Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment

Start date: November 29, 2019
Phase:
Study type: Observational

The prognosis in cancer patients has improved over the years. Survivor rates have increased significantly, and paternity has become an important concern in more than 50% of young male survivors. Sperm cryopreservation before cancer treatment is highly recommendable in these patients, as a strategy to preserve their fertility due to is not possible to predict how the chemo or radiotherapy treatment will affect the spermatogenesis. The objective of this study is to evaluate if sperm after an antineoplastic treatment can be safely used. To determine the possible effects of oncological treatments in the spermatogenesis, three parameters will be analyzed, aneuploidy frequencies, DNA fragmentation in single and double-strand breaks and methylation levels to determine epigenetic changes before and after the therapy. If cancer treatment affect sperm genetic integrity, it would have a clinical impact in the offspring of these patients. Identify the different side effects of antineoplastic treatments in DNA sperm will provide a clinical improvement in order to select the best sperm sample in an IVF treatment and it will facilitate genetic counseling

NCT ID: NCT04158765 Recruiting - Male Infertility Clinical Trials

The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments

Start date: November 20, 2019
Phase:
Study type: Observational

This aim of this study is to determine the impact of lifestyle on telomere length and telomerase enzyme activity on sperm cells of men undergoing IVF treatments.

NCT ID: NCT03864198 Recruiting - Male Infertility Clinical Trials

To Evaluate the Effect of Reveratrol,Folic Acid, Vitamin D, Vitamin B12 and B6 in Male Infertility

Start date: January 20, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the impact of the Genante(TM) on the spermiogram parameters in infertile male patients

NCT ID: NCT03726450 Recruiting - Male Infertility Clinical Trials

Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate if Myo-inositol, N-Acetyl-Cysteine plus a cocktail of antioxidants could be able to increase spermatozoa parameters and reduce semen hyper-viscosity

NCT ID: NCT03475199 Recruiting - Male Infertility Clinical Trials

Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

FabLife
Start date: February 13, 2018
Phase: N/A
Study type: Interventional

FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France. The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.

NCT ID: NCT03307655 Recruiting - Male Infertility Clinical Trials

Relationship Between Nitric Oxide (NO) in Follicular Fluid and Sperm Fertilization Ability

Start date: September 21, 2017
Phase: N/A
Study type: Interventional

Several studies indicate that Nitric Oxide (NO) plays an important role in the physiology of the reproductive system in mammals. It has been shown that NO affects sperm motility, it regulates the tyrosine phosphorylation of different sperm proteins, it enhances the sperm binding ability to the zona pellucida and it modulates the acrosome reaction. The enzyme responsible for NO synthesis, the Nitric Oxide Synthase (NOS), has also been identified in the oocytes, cumulus and corona cells, as well as in the oviduct. For these reasons, the NOS presence at the fertilization site could be a key element to determine the success of this process. Therefore, carrying out in vitro studies to better understand NO's role in the fertilization process, especially in human sperm capacitation, could improve the outcome of the Assisted Reproductive Techniques (ARTs) due to an improvement both in the diagnosis of infertility and in the prognosis of treatment success. This study is carried out in collaboration with the Animal Physiology Department from the Veterinary Faculty (University of Murcia, Spain) and it is funded by the European Commission under the Horizon 2020 Programme.

NCT ID: NCT02864329 Recruiting - Male Infertility Clinical Trials

Small RNA Pathways in Mammalian Gametogenesis

Start date: April 2014
Phase:
Study type: Observational

Basic and clinical research is revealing that various noncoding and small RNAs play important and diverse roles in germ cell development and quality, including X/Y silencing during meiosis, gene regulation, DNA damage responses, and protection of the genome against transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human infertility are largely uncharacterized. The goal of this study is to elucidate the role of small RNA pathways in the events that give rise to viable euploid gametes. Four projects and three cores are included in this study.

NCT ID: NCT01856361 Recruiting - Male Infertility Clinical Trials

Ramipril for the Treatment of Oligospermia

Start date: July 2013
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to evaluate the effect of ramipril in stimulating and promoting sperm production in men with low sperm count. Ramipril is an Angiotensin Converting Enzyme Inhibitor (ACEI) currently used to treat high blood pressure. However, previous studies have shown that this class of medications can improve sperm parameters. The purpose of this study is to evaluate the efficacy of ramipril compared to placebo (Substance That is not known to have treatment effect), in improving sperm density in infertile men with documented low sperm count. This study will help us identify subjects that might benefit from treatment with this medication, and the effect it will have on sperm count, shape, and motility.