Reviews on recent clinical trials最新文献

{"title":"Immune Checkpoint Inhibitors Impact Fertility: A Review.","authors":"Iram Shabir, Christina Foster","doi":"10.2174/0115748871340496250130054721","DOIUrl":"https://doi.org/10.2174/0115748871340496250130054721","url":null,"abstract":"<p><p>Immune checkpoint inhibitor therapy has become the established method of treatment for various types of cancers, consequently introducing a spectrum of side effects referred to as immune- mediated adverse events, affecting almost every organ, including the reproductive system. Moreover, very little clinical data is available that suggests the detrimental effect of immune checkpoint inhibitor therapy on fertility, sexual health, or potential pregnancies. In this manuscript, we reviewed the impact of immunotherapy on male and female fertility and its effect on sexual health. Patients undergoing systemic treatment with immunotherapy often experience sexual dysfunction, decreased sexual drive, erectile dysfunction, and a decline in vaginal lubrication. Fertility-desiring patients who do not receive adequate counseling may ultimately face a higher likelihood of developing anxiety, depression, and a decreased quality of life post-treatment. Therefore, it is crucial to address the reproductive consequences of planned treatment, disseminate knowledge about novel treatments and preventive measures for reproductive side effects, and provide guidance on fertility preservation. Individuals experiencing secondary reproductive dysfunction due to the tumor or its treatment should receive proactive treatment for the underlying condition and be offered hormone replacement therapy.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143365758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Critical Analysis of Non-profit Clinical Trials: Three Years of Activity at the Clinical Trials Office.","authors":"Diego Alejandro Dri, Marta De Cata, Maria Carafa, Eleonora De Paola, Raffaella Maione, Paola Aita, Donatella Gramaglia","doi":"10.2174/0115748871310179250109065608","DOIUrl":"https://doi.org/10.2174/0115748871310179250109065608","url":null,"abstract":"<p><strong>Introduction: </strong>Non-profit clinical trials submitted for authorization over three years to the Clinical Trials Office of the Italian Medicines Agency were reviewed and critically analyzed.</p><p><strong>Objective: </strong>The objectives are to highlight potential trends following the full implementation of Regulation (EU) No. 536/2014 and to reveal the different nuances of non-profit clinical trials, comparing them with the general profile of all clinical trials.</p><p><strong>Methods: </strong>Using a multidisciplinary approach, the research navigates public data, official documents and data retrieved from the Italian National Observatory on Clinical Trials and from the European Clinical Trials Information System to reveal shifts in the clinical trials landscape.</p><p><strong>Results: </strong>A decrease in non-profit applications submitted in the 2020-2022 timeframe is emerging, clearly related to the new regulatory complexities and uncertainties in the adoption of the Clinical Trials Information System platform. Results also show a divergence between nonprofit and overall clinical trials in terms of authorization outcomes, also including studies with a COVID-19 indication. Further comparing non-profit studies with the total number of clinical trials across different characteristics, such as phases, therapeutic areas and study purposes, increases transparency and availability of insight information.</p><p><strong>Conclusion: </strong>Relevant data are provided as a result of the review and analysis of non-profit clinical trials, highlighting specific features. Overall, this critical analysis provides an overview of recent trends and, also promotes insights for further consideration by regulators to adequately support clinical research in a complex and evolving regulatory environment.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fully Covered Self-Expandable Metal Stents for the Treatment of Leak after Oncologic Gastroesophageal Surgery: A Cohort Study.","authors":"Carmelo Luigiano, Milena Di Leo, Marco Magistroni, Giuseppe Iabichino, Monica Arena, Pierluigi Consolo, Maria Angela Palamara, Ludovico Abenavoli, Luca De Luca","doi":"10.2174/0115748871324401250114101416","DOIUrl":"https://doi.org/10.2174/0115748871324401250114101416","url":null,"abstract":"<p><strong>Background: </strong>Anastomotic leakages are one of the most frequent complications of gastroesophageal surgery with a high mortality.</p><p><strong>Objective: </strong>This study aimed to assess the efficacy and safety of endoscopic therapy using fully covered self-expanding metal stents (FC-SEMS) for the management of anastomotic leaks.</p><p><strong>Methods: </strong>In this cohort study, all patients with leak after oncological gastroesophageal surgery treated with FC-SEMS were included. Procedures were performed by one expert endoscopist in three Italian endoscopic units. The primary outcome was clinical success defined as complete resolution of clinical and laboratory manifestations of sepsis with radiological evidence of leak closure. Secondary outcomes were technical success, stent-related adverse events (AEs), and mortality.</p><p><strong>Results: </strong>28 patients (21.4% female, mean age 64.3 years) were included in the study, of whom 17 (60.7%) had undergone total gastrectomy, 9 (32.1%) Ivor-Lewis procedure, and 2 (7.1%) extended gastrectomy (transhiatal-abdominal approach). The leaks were located in esophagogastric anastomosis in 5 patients (17.9%), esophagojejunal anastomosis in 19 (67.9%), and esophagus in 4 (14.3%). A total of 34 stents were placed (mean of 1.2 per patient). Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 78.6% of patients. Stent-related early AEs occurred in 9 patients (32.1%, all were migration). Late AEs occurred in 21.4%, which all were treated endoscopically.</p><p><strong>Conclusion: </strong>Stenting therapy using FC-SEMS is a safe and effective modality for the management of anastomotic leaks.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From Paper to Digital: Evaluating Electronic Medical Records and their Compliance with EMA Guidelines in European Clinical Trials.","authors":"Stefano Stabile, Sara Testoni, Veronica Franchina, Marta Betti, Francesca Mannozzi, Alessandra Ferrari, Irene Federici, Ludovic Doungue, Celeste Cagnazzo","doi":"10.2174/0115748871363256250117172437","DOIUrl":"https://doi.org/10.2174/0115748871363256250117172437","url":null,"abstract":"<p><strong>Background: </strong>Over the past decade, there has been a significant shift from paper-based to digital medical record management, driven largely by advances in digital technology. This transition has led to widespread adoption of Electronic Medical Records (EMRs), with the expectation that paper documentation will soon be fully replaced. In response, the European Medicines Agency's \"Guideline on Computerised Systems in Clinical Trials\" outlines essential criteria for validated EMR systems to ensure data integrity and security, and sets standards for electronic source documents in clinical trials.</p><p><strong>Methods: </strong>From December 2023 to March 2024, the Italian Group of Data Managers and Clinical Research Coordinators (GIDMcrc) conducted an online survey across clinical research sites in Italy, France and Belgium to assess the characteristics of medical records and source documents.</p><p><strong>Results: </strong>The survey was completed by 37 centres: 70.3% from Italy, 16.2% from France and 13.5% from Belgium. Most sites use a mixed paper/electronic Source Document (SD) system (72.3%), with fewer centres having fully electronic SD systems (13.5%) or fully paper-based systems (16.2%). EMR systems are used in 70.3% of sites, but only 23.8% comply with EMA guidelines for computerised systems. A country-specific analysis was also conducted to further explore the situations in Italy and France/Belgium.</p><p><strong>Conclusion: </strong>Despite the widespread use of electronic medical records (EMRs) in Italy, France and Belgium, Italy lags behind the other two countries in terms of digitization. Despite the presence of an EMR, many centres still use a mixed system of paper and electronic source documents. There is also a lack of awareness regarding EMA and GCP standards, particularly concerning training and system testing. The higher response rate from Italian centres highlights the need for a larger sample in France and Belgium, and a follow-up survey would be beneficial for assessing progress and refining corrective actions.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Research on Biomarkers in Alzheimer's Continuum.","authors":"Immacolata Vecchio, Carmela Colica","doi":"10.2174/0115748871331138250114052615","DOIUrl":"10.2174/0115748871331138250114052615","url":null,"abstract":"<p><p>Alzheimer's disease (AD) is a multifactorial pathology, responsible for neurodegenerative disorders which in more than 60% of patients evolve into dementia. Comprehension of the molecular mechanisms underlying the pathology and the development of reliable diagnostic methods have made new and more effective therapies possible. In recent years, in addition to the classic anticholinesterases (AChEs), which can control the clinical symptoms of the disease, compounds able to reduce deposits of amyloid-β (Aβ) and/or tau (τ) protein aggregates, which are disease-modifying therapeutics (DMTs), have been studied. The results have shown that symptomatic therapy works best when administered in the disease's mild to moderate clinical phase. On the other hand, treatment with DMTs has been found to be more effective in the preclinical stage of AD, when Aβ and τ protein neurofibrillary tangles have not yet been compromised and patients still have a normal quality of life. This innovative approach requires the identification of specific biomarkers predictive of the disease, detectable many years before clinical signs are evident. Biomarkers allow early diagnosis, give indications of the possible development of dementia in the future, and make it possible to study the evolution of the disease. New scenarios, involving different pathways and approaches, could emerge and provide effective therapies to treat the very early stages of the disease and hamper its progression. The specific biomarkers studied so far have been reported here.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blockchain as a Prime Guardian: Securing Clinical Trial Data Integrity.","authors":"Nikhil Sethi, Charul Rathore, Dilpreet Singh","doi":"10.2174/0115748871357146250116113310","DOIUrl":"https://doi.org/10.2174/0115748871357146250116113310","url":null,"abstract":"<p><p>The present study focuses on the possible use of the emerging technology of blockchain in ensuring data management security in clinical trials. With the determination of the chief researchers and clinical investigations becoming more and more complex and international, achieving data quality and integrity, transparency, and legal compliance becomes imperative. By offering a distributed and immutable time-stamped ledger, issues of data revisions, selective data release, and the usually time-consuming issue of compliance auditing are well addressed. With this technology, it is possible to conduct surveillance of multi-center studies without compromising the confidentiality of patients while allowing the researchers to have unbiased information. When it comes to internal accountability, the use of the blockchain will create a situation whereby no alteration of the documents will take place. Thus, regulatory oversight is improved with the engagement of these parties. In addition, it makes sure that the need for bias in the reporting of outcomes is avoided in all trials and all results reported whether positive or negative. In order to address clinical trial data management and clinical trial outcomes' validity and reliability, this review provides reputation management through digital ledger technology in the real world.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Empagliflozin Ameliorates the Oxidative Stress Profile in Type 2 Diabetic Patients with Heart Failure and Reduced Ejection Fraction: Results of a Randomized, Double-blind, Placebo-controlled Study.","authors":"Azadeh Eshraghi, Somayeh Khalesi, Kiumarth Amini, Fahmi Hassan Salleh, Mahdis Sharifikia, Minoo Sadat Hajmiri, Maryam Zamanirafe, Amirhossein Yazdi, Maryam Mehrpooya","doi":"10.2174/0115748871323540241212060946","DOIUrl":"https://doi.org/10.2174/0115748871323540241212060946","url":null,"abstract":"<p><strong>Introduction: </strong>In the present study, we evaluated the impact of empagliflozin on serum levels of oxidative stress parameters in individuals with type 2 diabetes (T2DM) who also suffer from heart failure with Reduced Ejection Fraction (HFrEF).</p><p><strong>Methods: </strong>In this prospective, single-center clinical trial, 80 patients with T2DM and HFrEF, stabilized on guideline-directed heart failure therapy and classified as New York Heart Association functional (NYHA) functional classes II or III, were randomized to receive either empagliflozin (10 mg/daily) or a matching placebo for a duration of 12 weeks. Serum levels of malondialdehyde (MDA), along with the activity of superoxide dismutase (SOD) and glutathione peroxidase (GPx), were measured at baseline and after the 12-week treatment period.</p><p><strong>Results: </strong>The baseline demographic and clinical characteristics of the randomized patients were comparable across the study groups. As anticipated, empagliflozin demonstrated a significant reduction in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) compared to the placebo after 12 weeks of treatment. Additionally, in comparison to the placebo, empagliflozin significantly increased the antioxidant capacity by elevating serum activity of SOD and GPx, while reducing oxidative damage, as evidenced by diminished MDA levels. Empagliflozin-treated patients also experienced greater improvement in their NYHA functional classes by week 12, though no significant changes in Left Ventricular Ejection Fraction (LVEF) were observed.</p><p><strong>Conclusion: </strong>The findings of this study shed light on the potential mechanisms through which SGLT2 inhibitors exert their beneficial effects on clinical outcomes in diabetic patients with HFrEF. This provides compelling evidence supporting the cardio-protective of SGLT2 inhibitors in this patient population.</p><p><strong>Clinical trial registration number: </strong>The trial was registered at the Iranian Registry of Clinical Trials (https://irct.behdasht.gov.ir/trial/72825, identifier code: IRCT20120215009014N484). Registration date: 2022-09-30.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142954108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multicentric Post-marketing Surveillance (PMS) Observational Study of Ascorbic Acid and Zinc Effervescent Tablets in Indian Patients with Vitamin C and Zinc Deficiency.","authors":"Ruchika Swami, Sunena","doi":"10.2174/0115748871306324240827105922","DOIUrl":"10.2174/0115748871306324240827105922","url":null,"abstract":"<p><strong>Aim: </strong>The objective of this Multicentric Post-Marketing Surveillance (PMS) study was to evaluate the safety and tolerance of vitamin C and zinc tablets in the Indian population experiencing deficiencies of these nutrients. Furthermore, the study aimed to provide insights into physicians' prescription practices and characterise the patient population receiving the study medication.</p><p><strong>Methods: </strong>This prospective observational study involved 358 participants from 8 study sites across India (including 2 government hospital sites), spanning a duration of approximately 12 weeks (3 months). The primary aim was to evaluate the safety and tolerability of zinc and ascorbic acid effervescent tablets for those who were deficient in zinc and vitamin C. Throughout the study period, adverse events were monitored and categorised by MedDRA Primary System Organ Class and Preferred Term. The analysis included evaluating the incidence, percentage, and correlation of adverse events with the treatment (safety population). Additionally, the frequencies of adverse drug reactions were examined across all enrolled patients. Vital signs and symptom-focused physical examinations were conducted during each visit in the safety population.</p><p><strong>Results: </strong>Out of 358 (100%) patients, only 12 (3.35%) experienced minor symptoms in the study period. The majority of patients reported gastrointestinal disorders, i.e., two (0.6%) patients reported constipation and gastritis, respectively. Diarrhoea was reported by four (1.1%) patients. One (0.3%) patient reported gastrointestinal pain. Three (0.8%) patients reported vomiting. Diarrhoea was the most common symptom reported. All patients possess a mild intensity of adverse drug reactions in safety populations. The p-value is less than 0.05 (p-value < 0.05), and therefore there is a statistically significant relationship between the predictor variables and the response variable (i.e., the expected count of adverse drug reactions).</p><p><strong>Conclusion: </strong>The fixed-dose combination of vitamin C and zinc effervescent tablets appears to be safe and tolerable for the treatment of vitamin C and zinc deficiencies in Indian patients. The favorable outcome underscores the mild nature of the adverse reactions and the right medical interventions and support.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"45-51"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142294204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review of Association between Urinary Tract Infections and Immunosuppressive Drugs after Heart Transplantation.","authors":"Zahra Tolou-Ghamari","doi":"10.2174/0115748871315445240916091528","DOIUrl":"10.2174/0115748871315445240916091528","url":null,"abstract":"<p><p>Management of infections in heart transplant recipients is complex and crucial. In this population, there is a need for a better understanding of immunosuppressive trough levels (C0), infectious complications, and urinary tract infections (UTIs). The purpose of this review was to understand the association between immunosuppressive trough levels and UTIs after heart transplantation. A review of scientific literature (n= 100) was conducted based on the topic of interest by searching PUBMED.Gov (https://pubmed.ncbi.nlm.nih.gov/), Web of Science, and Scopus. The analysis of bacterial pulmonary infection required the occurrence of new or deteriorating pulmonary infiltrates and the development of organisms in cultures of sputum specimens. The diagnosis of UTIs was based on the result of related signs, pyuria, and a positive urine culture. The incidence of UTIs was reported as 0.07 episodes/1000 regarding heart transplantation days. An eightfold increase in the rate of rejection was noted in heart transplant recipients with higher variability in tacrolimus C0. There are associations between C0 of immunosuppressive drugs and clinical presentation of infection complications. Recipients with a low metabolism of immunosuppressive drugs are more susceptible to infectious complications. Attention to the biology of herpes viruses, <i>Escherichia coli, Enterococcus spp., Pseudomonas aeruginosa</i>, and <i>Staphylococcus saprophyticus</i> after heart transplantation are important, in which some of them are the most common pathogens responsible for UTIs. Pneumocystis and cytomegalovirus affect all transplant recipients. Pneumonia due to bacterial, viral, protozoa, and fungal infections, in addition to UTIs, are more specific reported types of infections in heart transplant recipients. Bacterial infections produced by extensively drug-resistant Enterobacteriaceae, vancomycin-resistant enterococci, and non-fermenting gramnegative bacteria were reported to increase after transplantation.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"18-26"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142352950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Seminal Plasma Malondialdehyde Acid as a Diagnostic Tool for Male Infertility: A Case-Control Study.","authors":"Naina Kumar, K N Deepthi, Suhasini Padugupati, Seetesh Ghose","doi":"10.2174/0115748871306544240826095508","DOIUrl":"10.2174/0115748871306544240826095508","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to assess the role of seminal Malondialdehyde Acid (MDA) in the diagnosis of male infertility.</p><p><strong>Background: </strong>Both male and female infertility is increasing all over the world.</p><p><strong>Objective: </strong>The purpose of this study was to assess the impact of seminal MDA levels on various semen parameters of healthy fertile men and men with infertility, and to know the efficacy of seminal MDA in the diagnosis of male infertility.</p><p><strong>Methods: </strong>This case-control study was carried out at the Department of Obstetrics and Gynaecology of a tertiary care center in rural Southern India over a period of two years. The study included 90 infertile men (≥21-50 years) having some pathology in semen reports as cases and 90 fertile men (having biological children) with normal semen reports as controls. Biochemical tests for MDA were performed using Human MDA Assay kits on 180 cryopreserved semen samples following the standard protocol. Results of seminal MDA levels were assessed among cases and controls and correlated with different semen parameters.</p><p><strong>Results: </strong>The mean±SD age for cases was 30.10 ± 4.75 years, and for controls, it was 29.79 ± 5.08 years. Of all the cases, 44 (48.9%) had asthenozoospermia, 22 (24.4%) had oligoasthenozoospermia, 14(15.6%) had oligozoospermia, and 10 (11.1%) had azoospermia. A statistically substantial variance was observed in mean values of MDA (1.03 ± 0.31 mmol/mL vs. 0.60 ± 0.14 mmol/mL; p =0.001) between fertile men and men with abnormal semen reports. A negative association was observed between semen MDA levels with sperm motility, concentration, and normal morphology in 180 participants. The sensitivity of MDA for male infertility prediction was 86.67% at 76.67% specificity, 78.79% positive predictive value, and 78.79% negative predictive value.</p><p><strong>Conclusion: </strong>MDA has been found to be a promising biomarker for predicting male infertility. However, large sample sizes and prospective cohort studies are required to further confirm its predictive accuracy across various populations.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"36-44"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}