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Infertility, Male clinical trials

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NCT ID: NCT06384794 Recruiting - Infertility, Male Clinical Trials

Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.

ZYMOT2
Start date: June 29, 2023
Phase: N/A
Study type: Interventional

It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.

NCT ID: NCT06358794 Completed - Infertility, Male Clinical Trials

Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate

Start date: June 1, 2022
Phase:
Study type: Observational

Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models.

NCT ID: NCT06335706 Not yet recruiting - Infertility, Male Clinical Trials

The Influence of Fit of Underpants Worn on Semen Quality

Start date: March 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are: - Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity. - Determining the prevalence of preferred type of underpants worn by Thai males. The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample.

NCT ID: NCT06324071 Recruiting - Male Infertility Clinical Trials

Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg/day) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility.

NCT ID: NCT06307639 Not yet recruiting - Clinical trials for Male Infertility Due to Azoospermia

Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

- Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE). - Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples.

NCT ID: NCT06300229 Not yet recruiting - Infertility, Male Clinical Trials

NAPO - Novel Approach for Oligospermia

NAPO
Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL).

NCT ID: NCT06257459 Recruiting - Male Infertility Clinical Trials

Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery

NCT ID: NCT06241495 Not yet recruiting - Infertility, Male Clinical Trials

Aromatherapy in Providing a Semen Sample

Start date: January 29, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage. The study will be carried out in two different groups. After the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. The random distribution of men to the study groups will be carried out random. The following applications will be made to the groups. Aromatherapy/placebo will be applied to the individuals included in the study. During the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.

NCT ID: NCT06210568 Recruiting - Male Infertility Clinical Trials

Oxidative Stress and Male Infertility.

Start date: June 27, 2023
Phase:
Study type: Observational

Study Aims: To evaluate the impact of oxidative and nitrosative stress, as well as DNA methylation, on male reproductive health. This is achieved by analyzing urinary biomarkers: 8-oxoGua, 8-oxoGuo, 8-oxodGuo, 3-nitrotyrosine (3-NO2Tyr), 5-methylcytidine (5-MeCyt), and cotinine in infertile and fertile males. Study Design: A prospective observational case-control study comparing infertile male patients (cases) from a reproductive sciences center with fertile male volunteers (controls) from a gynecology and obstetrics department. The study focuses on understanding the role of oxidative stress in male infertility and its implications for assisted reproductive techniques.

NCT ID: NCT06193850 Recruiting - Urologic Diseases Clinical Trials

Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients

Start date: February 24, 2015
Phase:
Study type: Observational

Prospective observational study on the quality of life of patients attending general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.The data relating to the clinical conditions (disease state, psychological and related to quality of life) of the patients belonging to the above-mentioned clinics will be collected in a specially designed database which will allow us to extract the data in a simple and safe way used for statistical analyses. in clinical research.