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Infertility, Male clinical trials

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NCT ID: NCT06188936 Recruiting - Male Infertility Clinical Trials

Home Semen Analysis Tests as a Screening Tool for Fertility Patients

Start date: November 8, 2023
Phase: N/A
Study type: Interventional

Infertility, defined as the inability to conceive after 12 months of regular unprotected intercourse, is estimated to affect 1 in 7 heterosexual couples. Semen analysis, carried out as per the detailed World Health Organisation (WHO) standards in an andrology laboratory, is the primary investigation for the male partner presenting to the fertility clinic and reports on multiple semen parameters. Hospital clinic attendance is required, which could be at a significant distance from the patient's home, to produce a sample at a given appointment time that is then analysed by the laboratory without delay, as the results are time sensitive. A formal report is produced after several weeks. This process was not sustainable during the Covid pandemic and these methods would be threatened by similar situations in the future. Despite semen analysis being an essential component of fertility work-up the WHO themselves state that the test does not distinguish between fertile and infertile men. In addition, it involves a significant cost to the national healthcare system. Therefore, a more efficient initial test of male fertility warrants consideration. Home semen analysis tests are a screening tool that provide a simplified, initial assessment. They are widely available to purchase in the UK, but are not currently issued to patients seen in NHS clinics. They have the potential to reduce time to diagnosis and reduce the cost to the healthcare provider. To investigate the clinical and cost effectiveness of using home semen analysis tests a randomised controlled trial (RCT) is needed comparing them to laboratory semen analysis (standard care). Before a fully-fledged national trial is planned in a UK setting, the investigators would like to undertake a feasibility study to answer, "Is it feasible to conduct a trial comparing home semen analysis tests with current standard practice for the initial assessment of men referred to the fertility clinic?"

NCT ID: NCT06183255 Recruiting - Infertility Clinical Trials

"System Medicine" Approach for Prevention Strategies for Comorbidities in Infertile Men

Start date: January 18, 2021
Phase:
Study type: Observational

By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.

NCT ID: NCT06177002 Recruiting - COVID-19 Clinical Trials

SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

PROTEGGIMI
Start date: May 19, 2020
Phase:
Study type: Observational

The hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection.

NCT ID: NCT06161727 Completed - Clinical trials for Human Papilloma Virus

Detection and Prevalence of Human Papillomavirus (HPV) in Seminal Plasma and/or on Sperm in Men Undergoing Treatment With IVF/ICSI.

Start date: January 1, 2023
Phase:
Study type: Observational

This observational study aims to investigate the presence of HPV DNA in semen samples from men undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment. It focuses on understanding the impact of HPV on male fertility and embryo development following IVF/ICSI. The primary goal is to determine the prevalence of HPV-positive (HPV+) semen samples among men seeking infertility treatment with IVF/ICSI. Additionally, the study aims to compare semen characteristics between HPV-positive and HPV-negative (HPV-) samples and assess the embryological outcomes after IVF/ICSI in these two groups. Participants in this study will include men receiving IVF/ICSI treatment and providing fresh ejaculated sperm at Sahlgrenska University Hospital in Gothenburg, Sweden, over one year. Those undergoing treatments with surgically extracted sperm, sperm freezing for fertility preservation, or planning treatments involving preimplantation genetic testing or egg donation will be excluded. The study will involve analyzing HPV DNA in semen samples through PCR, utilizing the most effective method for HPV DNA detection previously identified in a pilot study. Sperm samples collected during infertility investigations and IVF/ICSI treatments will undergo gradient centrifugation to separate different components. A portion of the sperm sample will be preserved for PCR analysis to detect HPV DNA, while the rest will be used for IVF/ICSI procedures. The results from the PCR analyses will be correlated with semen characteristics and the outcomes of IVF/ICSI treatment. Furthermore, the samples will be stored for potential future analyses related to HPV-related biomarkers for up to 5 years at Biobank.

NCT ID: NCT06147700 Recruiting - Male Infertility Clinical Trials

Identifying Molecular Determinants of Infertility in Men (MODIFY)

Start date: October 11, 2023
Phase:
Study type: Observational

The purpose of this study is to understand the underlying mechanisms of infertility caused by unknown factors. The investigator propose to identify small non-coding RNA (sncRNA) biomarkers of infertility and advance towards developing a more accurate and robust approach for infertility diagnosis.

NCT ID: NCT06100432 Recruiting - Male Infertility Clinical Trials

Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ β-carotene) for Infertile Males

Start date: November 11, 2023
Phase: Phase 4
Study type: Interventional

Infertility is defined as the inability of a couple to get pregnant after one year of regular and unprotected sexual intercourse. Although it is not a life-threatening condition, infertile couple often suffer from mental health issues, including depression and low self-esteem that may impact their Quality of Life (QoL). Male factors contribute to a half of the underlying causes of infertility and semen analysis play a vital role in investigation of the fertility status of the male partners. By performing semen analysis, we could predict the chance of a couple to conceive. Male infertility treatments include surgery, hormonal treatment and also assisted reproductive techniques, such as intra uterine insemination and in vitro fertilization that may lead to a financial burden for infertile couple. For facing this issue, traditional or herbal medicine and antioxidants are often be used as an alternative way by many infertile couples. One of the traditional medicines used in Indonesia and other Southeast-Asia Countries for infertility cases is Eurycoma longifolia or Pasak Bumi. Based on previous studies in animals, Eurycoma longifolia could improve Testosterone and may improve sperm parameters, even though there are very few studies in human including in Indonesia. Antioxidants (multivitamins) are also routinely given to the infertile men as they could protect sperm damages from oxidative stress and may in advanced improve sperm quantity and quality. Our study aims to compare the effect of Eurycoma longifolia, Multivitamins and the combination on sperm parameters and also reproductive hormones of the infertile males.

NCT ID: NCT06091969 Not yet recruiting - Male Infertility Clinical Trials

Supplementation for Male Subfertility

FertEnhancer
Start date: February 2, 2024
Phase: Phase 2
Study type: Interventional

Old age, physical inactivity, environmental factors and genetics may contribute negatively to fertility in both males and females. In males, specifically, certain supplements, such as single antioxidants and trace minerals, have previously been shown to improve sperm function marginally. One hypothesis is that sperm function can be improved even further by combining several different types of supplements (e.g., amino acids, energy carriers, vitamins, antioxidants, and trace minerals) to target several age-related cell pathways, for example, oxidative stress, mitochondrial dysfunction, inflammation and cell energetics. This 3-month placebo-controlled, randomized clinical trial, aims to test the effects of a novel multi-ingredient supplement (Fertility Enhancer) that targets several age-related cell pathways on sperm function in subfertile males.

NCT ID: NCT06082362 Recruiting - Male Infertility Clinical Trials

Personalized Signature of Chronic Inflammation and Early Aging Predictive of the Comorbidities in Infertile Men

Start date: June 21, 2023
Phase:
Study type: Observational

The aim of the project is identify new biomarkers and/or prognostic factors in order to develop personalized strategies to prevent the onset of tumor and/or non tumor comorbidity in infertile men.

NCT ID: NCT06050031 Not yet recruiting - Infertility, Male Clinical Trials

Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility

Start date: November 2023
Phase:
Study type: Observational

The investigators will investigate the effect of antioxidants and lifestyle factors on the level of oxidative stress. As oxidative stress cannot be directly measured, it will be approximated by the DNA fragmentation index (DFI) which reflects the level of DNA damage in sperm caused by oxidative stress.

NCT ID: NCT06045702 Not yet recruiting - Cystic Fibrosis Clinical Trials

Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation

CFTR-EP
Start date: September 2023
Phase:
Study type: Observational

The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery. The main questions it aims to answer are: - to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model. - to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis. Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..