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Azoospermia clinical trials

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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: 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: NCT06181851 Recruiting - Clinical trials for Azoospermia, Nonobstructive

2015-Metabolomics&Microbiome-infertility

Start date: June 1, 2016
Phase:
Study type: Observational

The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

NCT ID: NCT06154954 Recruiting - Clinical trials for Non-obstructive Azoospermia

Testicular Proteins for Sperm Retrieval Prediction Protein1, Testis-Expressed Gene 101, and Lectin Galactoside-binding Protein in Predicting Surgical Sperm Retrieval in Men With Non-Obstructive Azoospermia

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

Generally, azoospermia is characterized as obstructive (OA) or nonobstructive (NOA). Surgical spermatozoa retrieval results vary in success rates. Proposing Intracytoplasmic Sperm Injection (ICSI) to infertile couples with NOA depends on spermatogenesis, testicular histology, and the ability to extract live spermatozoa from testis biopsy pieces. Unfortunately, only 50% of testicular sperm extraction (TESE) results are positive (Zarezadeh et al., 2021). Repeating sperm retrieval can cause TESE-induced hypoganadism, including reduced testicular volume, erectile dysfunction, and testosterone deficiency (Eliveld et al., 2018; Okada et al., 2002; Ozturk et al., 2011; Altinkilic et al., 2017; Akbal et al., 2017; Binsaleh et al., 2017). The prognostic efficacy of hormonal, molecular, cytological, and biochemical indicators for effective sperm recovery is limited (Corona et al., 2019). Molecular, biochemical, clinical, and histopathological characteristics that identify NOA males with advanced spermatogenesis foci up to the spermatozoon stage are crucial for therapeutic purposes. Recent research suggests that seminal protein expression patterns change dramatically between azoospermic and fertile males (Zhang et al., 2021). TEX101 is a membrane protein only produced by testicular germ cells and shed into seminal plasma (SP). Research suggests that Tex101 malfunctions may impact male fertility (Jarvi et al., 2021). TEX101 is a germ cell mono-specific marker present on sperm, round spermatids, and spermatocytes. At a threshold of >5 ng/mL, TEX101 can distinguish NOA with Sertoli-cell only syndrome from other testis histologies, such as hypospermatogenesis (67% specificity, 100% sensitivity) or maturation arrest (54% sensitivity, 100% specificity) (Drabovich et al., 2013). ECM1, an epididymal mono-specific marker, was below detection limits in males with OA semen but present in detectable levels. Research Template 3: Final Version: April 2019 NOA amounts in males. Clinical immunoassays of ECM1 and TEX101 can predict sperm retrieval outcomes for assisted reproduction and lower the cost of diagnosing azoospermia. ELISA confirms that the lectin galactoside-binding, soluble 3 binding protein (LGALS3BP) is expressed throughout the male genital tract. Its physiological role in cell-to-cell interaction through extracellular matrix suggests a possible role in spermatogenesis, particularly in the late stage, despite not being a germ-cell specific marker (Cannarella et al., 2020). Patients with a good result of TESE had significantly greater levels of LGALS3BP in the SP. A cut-off of 153 ng/mL was observed with 100% sensitivity and 45% specificity. Freour et al. (2013) identified a key issue in their analysis due to the small number of instances (n=40) with lower AUC values. Araujo and Bertolla (2021) propose that LGALS3BP may predict TESE success in NOA patients before ICSI.

NCT ID: NCT05958576 Completed - Clinical trials for Non-obstructive Azoospermia

Effect of Age on Sperm Recovery of Microdissection Testicular Sperm Extraction in Nonobstructive Azoospermia Patients

Start date: March 1, 2012
Phase:
Study type: Observational

Males with non-obstructive azoospermia (NOA) have an opportunity to obtain sperm by treatment with microdissection testicular sperm extraction (mTESE), gold-standard surgical technique for them. The overall sperm retrieval rate (SRR) of mTESE in NOA patients is about 50%, but the predictive factors of SRR remain were understudied, especially the effect of age. The purpose of this study was to explore the factors influencing the SRR of mTESE in NOA patients with different etiologies. Methods: This observational study recruit NOA patients treated with their first mTESE. The stratified research was used to investigate SRR by dividing patients into seven groups based on etiology. The primary outcome was SRR. Multivariable logistic regression was used to analyze the factors influencing SRR.

NCT ID: NCT05866484 Active, not recruiting - Infertility, Male Clinical Trials

Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)

TESA vs Zymot
Start date: May 10, 2023
Phase:
Study type: Observational

Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate. The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI

NCT ID: NCT05631509 Recruiting - Genetic Disease Clinical Trials

Genetic Study of Obstructive Azoospermia

Start date: July 1, 2021
Phase:
Study type: Observational

In 1% of men with infertility, obstructive azoospermia (OA) may occur in congenital absence of the vas (CAVD) or idiopathic obstructive azoospermia . Many studies have shown that the pathogenic genes of OA are CFTR and ADGRG2 genes, and the inheritance mode is autosomal recessive. Although the conventional assisted reproductive technology(PESA/TESA) can help these patients have children, male patients who carry mutations of the disease-causing genes (CFTR and ADGRG2) will also pass on their mutations to the next generation, which will increase the risk of male offspring infertility. Therefore, genetic detection of CFTR and ADGRG2 genes is very necessary for CAVD patients before assisted reproduction. Genetic diagnosis plays a key role in preventing the disease to the offspring.

NCT ID: NCT05628987 Recruiting - Infertility, Male Clinical Trials

The Association of Gut Microbiota and Spermatogenic Dysfunction

Start date: February 20, 2023
Phase:
Study type: Observational

This is a multicenter, case-control study that aims to investigate the relationship between microbiota and sperm quality via stool, blood, and urine microbiome, metabolomics, and collected clinical metadata. The results of the spermatogenic dysfunction, including aspermia, oligozoospermia, asthenozoospermia, and teratozoospermia, will be compared to normal basic semen analysis utilizing the World Health Organization (WHO) semen analysis procedure 5th edition.

NCT ID: NCT05483621 Completed - Clinical trials for Azoospermia, Nonobstructive

Hormonal Stimulation of Spermatogenesis

Start date: March 1, 2021
Phase: Phase 1
Study type: Interventional

Urologists and reproductive specialists are often challenged when facing patients with severe male infertility scenarios. In particular, the treatment of men with NOA demands a deeper insight. In such cases, .

NCT ID: NCT05479474 Recruiting - Male Infertility Clinical Trials

Platelet Rich Plasma Testis Treatment for Infertile Men

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.