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Infertility, Male clinical trials

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NCT ID: NCT04761250 Completed - Infertility, Male Clinical Trials

The Effect of a Multimodal Lifestyle Program on Male Fertility

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment. The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment

NCT ID: NCT04717362 Withdrawn - Infertility, Male Clinical Trials

The Effects of Natesto For Treatment Of Hypogonadism

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

In this prospective study, the investigators plan is to confirm the role of Natesto (intranasal testosterone) to combat hypogonadal symptoms in men trying to recover spermatogenesis following the withdrawal of conventional Testosterone replacement therapy.

NCT ID: NCT04704141 Not yet recruiting - Male Infertility Clinical Trials

Relationship of the Microenvironment and Male Fertility

Start date: June 2023
Phase:
Study type: Observational

Although much is known about the microenvironment of the gut and the vagina, very little has been published on the microenvironment of the seminal plasma. The seminal plasma is the support fluid for sperm, providing nutrients, facilitating sperm transit to the uterus, and promoting fertilization. It is a rich area of research for markers of fertility and treatment targets. The investigators hypothesize that (1) there are significant populations of seminal microorganisms associated with seminal leukocyte counts well below the WHO's cutoff for pyospermia (1 million/mL) that were not previously detected by traditional culturing methods, and (2) there are pathologic populations of bacteria within the gut and semen microbiome which negatively impact overall fertility, by directly or indirectly impairing hormone status. Participants will be recruited from the Male Fertility practice at the University of Illinois-Chicago (UIC). All participants will have infertility, diagnosed as an inability to conceive pregnancy after 12 months of unprotected intercourse. The normal evaluation of these participants is to obtain at least one semen analysis and bloodwork investigating their endocrine profile: total testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and albumin. Semen volume is typically >1 mL, and <0.2 mL is typically used for the semen analysis. If over 1 million/mL round cells are identified, then a Papanicolaou stain would be performed to identify leukocytes. In this study, any semen demonstrated to have round cells would undergo Papanicolaou staining. A portion of the remaining semen, which would typically be discarded, will be sent for microbiome analysis. Secondly, as part of routine care, fertility patients may be started on medications to increase endogenous testosterone (i.e.: clomiphene citrate, anastrozole, etc). Participants started on medications will also be asked to submit a rectal swab for gut microbiome analysis. Routine care is to monitor the hormonal and testicular response with periodic endocrine blood panels and semen analyses; rectal swabs will be requested at these follow-up intervals also. The control group for both hypotheses will be men with clinical infertility with normal semen analyses and hormone profiles.

NCT ID: NCT04665258 Withdrawn - Infertility, Male Clinical Trials

Male Reproduction COVID Sequelae Study (MARCOS).

Start date: December 14, 2020
Phase:
Study type: Observational

The purpose of this study is to investigate the effects of COVID-19 Vaccination on semen parameters and to determine how long these possible changes may last following vaccination.

NCT ID: NCT04646291 Completed - Infertility Clinical Trials

Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit

Start date: August 5, 2020
Phase:
Study type: Observational

This study examines the experience of people who have selected to use the at-home insemination Mosie Kit to understand the user's experience, the perceived safety and the efficiency. People who have recently purchased and voluntarily selected to use the Mosie Kit will be invited to complete a one-time online anonymous survey. The results of the survey will be analyzed to understand their experiences.

NCT ID: NCT04628507 Not yet recruiting - Infertility, Female Clinical Trials

Cell Free Preimplantation Genetic Testing

Start date: June 11, 2024
Phase:
Study type: Observational

This study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). Genetic testing of culture media will be compared to conventional methods based on embryo biopsies.

NCT ID: NCT04608864 Not yet recruiting - Infertility, Male Clinical Trials

Varicocele Repair for Men Undergoing IVF/ICSI

Varicocele
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

For infertile men undergoing intracytoplasmic sperm injection (ICSI), data from retrospective studies suggested that varicocele repair may be beneficial and associated with improved livebirth and pregnancy rates, however, its role remains uncertain and disputed. To date, the investigators are not aware of published randomized controlled trail (RCT) that have evaluated whether varicocele repair would improve ICSI outcomes on patients with male-factor infertility.

NCT ID: NCT04591470 Completed - Clinical trials for Male Infertility Due to Antisperm Antibody

Influence of Inguinal Hernia Repair on Sperm Autoimmunity

SPERMAR
Start date: June 1, 2020
Phase:
Study type: Observational

Influence of inguinal hernia repair on sperm autoimmunity using MAR test

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.