Clinical Research Directory

Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils

The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess clinical safety and performance of the Concerto Versa™ Detachable Coils, when used in accordance with approved device labeling per the Instructions for Use (IFU). Data collected will generate clinical evidence to quantitatively assess clinical safety and device performance for the purpose of obtaining European Union Medical Device Regulation (EU MDR) approval.

Zonulin Levels in Varicocele Patients

This prospective cross-sectional observational study was designed to evaluate serum and seminal plasma zonulin levels in infertile men with clinically diagnosed varicocele and compare them with those in infertile men without varicocele. The study also aimed to investigate the association between zonulin concentrations and conventional semen parameters. A total of 119 men evaluated for infertility between December 2022 and May 2023 were included. Participants were classified into two groups according to the presence or absence of clinically diagnosed varicocele. Serum and seminal plasma zonulin concentrations were measured using enzyme-linked immunosorbent assay (ELISA). Conventional semen parameters, including semen volume, sperm concentration, total sperm count, progressive motility, total motility, and normal sperm morphology, were evaluated and compared between the study groups.

Recover@Home Postoperative Follow-up Study

This proposal describes a human subjects research study evaluating mHealth Ambulatory Surgery with Follow-up Nurse (Recovery@Home), as an alternative postoperative care pathway for selected low-acuity surgical procedures in Uganda. The Recovery@Home model discharges eligible patients home on the day of surgery and provides structured postoperative follow-up through nurse telephone calls, home visits, mobile-app documentation, escalation algorithms, and surgeon teleconsultation when clinically indicated. The proposed research includes a design to evaluate Recovery@Home against traditional postoperative inpatient care in a randomized controlled trial across three participating Ugandan surgical facilities.

Effects of Visceral Osteopathic Massage on Semen Parameters and Hemodynamics Factors in Varicocele

The project aims to evaluate the effects of a visceral osteopathic manual therapy (VOM) protocol on semen parameters and testicular hemodynamic indicators in men diagnosed with varicocele. Varicocele, the most common correctable cause of male infertility, is a progressive vascular pathology characterized by dilation of the pampiniform plexus veins and venous reflux. Multifactorial mechanisms such as venous valve insufficiency, increased intra-abdominal pressure, microcirculatory impairment, and oxidative stress play a role in the pathophysiology of varicocele. Therefore, the present study investigates the clinical effectiveness of a non-invasive rehabilitation approach aimed at regulating intra-abdominal pressure and improving pelvic venous drainage. The study will be conducted using a prospective, randomized controlled clinical design, including male participants aged 18-45 years diagnosed with varicocele. The intervention group will receive visceral osteopathic manual therapy techniques two times per week for eight weeks, while the control group will receive lifestyle recommendations only. Before and after the intervention, semen analysis results, sperm morphology, motility parameters, and testicular venous hemodynamic measurements obtained by color Doppler ultrasonography will be compared. Parametric and non-parametric statistical methods will be used in the analyses. This project aims to generate clinical evidence regarding conservative, complementary medicine-based treatment options in the field of male infertility. Compared to studies on female reproductive health, research focusing on male reproductive health is more limited; therefore, this study is expected to contribute to the literature in this area. The results are anticipated to support the development of a cost-effective and accessible model for infertility treatment processes. In addition, the project aims to provide scientific data for the development of sustainable reproductive health approaches in terms of health economics in Türkiye. The study seeks to determine the effects of visceral osteopathic manual therapy on varicocele-related semen parameters and hemodynamic variables and to contribute to the development of new evidence-based approaches in the management of male infertility.

Intratesticular Artery Resistive Index Changes After Varicocelectomy

This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels. Varicocele is a common, treatable cause of male infertility that can negatively affect testicular function by altering blood flow and temperature. While surgery (varicocelectomy) often improves fertility, doctors are continually looking for ways to predict which patients will benefit the most from the procedure. This study uses scrotal color Doppler ultrasound to measure the Intratesticular Artery Resistive Index (RI), which is an indicator of blood flow resistance and microvascular health, before and after surgery. Researchers will recruit 40 infertile men with clinically palpable varicoceles. Participants will undergo a baseline evaluation that includes a physical exam, semen analysis, a blood test for total testosterone, and a specialized ultrasound to measure the RI under different physical conditions (lying down, standing, and during a Valsalva maneuver/bearing down). All participants will then undergo a microscopic sub-inguinal varicocelectomy, which is the standard microsurgical treatment. Three months after the surgery, participants will return for follow-up testing to repeat the semen analysis, testosterone blood test, and ultrasound. The main goal of the study is to determine if pre-operative RI measurements can serve as an early, reliable predictor of surgical success, specifically looking at the recovery of testicular function, sperm parameters, and hormonal levels.

Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy

Evaluation of the impact of reflux flow volume and other ultrasonographic diagnostic parameters of varicocele on semen parameters before and 3 months varicocelectomy

Microscopic Varicocele Bypass Versus Ligation

This study, titled "A Prospective Randomized Controlled Study on the Safety and Efficacy of Microscopic Varicocele Transposition Surgery Compared with Simple Ligation," is conducted by the Urology and Andrology Department of Sichuan Provincial People's Hospital, with Dou Ke serving as the principal investigator. The research period spans from May 2025 to December 2027. It aims to compare the outcomes of microscopic varicocele transposition surgery and simple ligation in treating left varicocele through a prospective randomized controlled trial, focusing on postoperative recovery, complications, semen quality, and other aspects to provide evidence for clinical surgical selection. A total of 284 male patients will be enrolled, meeting criteria including clinical diagnosis of varicocele with surgical indications, aged 18-60 years, willing to participate and signing informed consent, abnormal semen analysis related to varicocele, no severe organ dysfunction, and no relevant treatments affecting the condition in the past three months. Exclusions include secondary varicocele, severe genitourinary or systemic diseases, coagulation disorders, drug allergies, mental/cognitive impairments, and participation in other related clinical trials. The experimental group will receive microscopic varicocele transposition surgery, while the control group will undergo microscopic simple ligation. Primary evaluation indicators include changes in spermatic vein diameter, reflux velocity, and duration assessed by color Doppler ultrasound at 1, 3, and 6 months post-surgery (with additional measurements of anastomotic vessel diameter and flow velocity in the experimental group), as well as pre- and post-surgery (3 and 6 months) semen routine parameters. Secondary indicators surgical success rate, postoperative complication rate, changes in reproductive hormone levels, pain relief evaluated by VAS scale, and quality of life improvements via specific assessment tools. Complying with the Declaration of Helsinki and approved by the ethics committee, informed consent will be obtained from all participants. Study results will be disseminated through academic papers, conference presentations, clinical research reports, and patient-focused summaries to advance new treatment directions for varicocele and optimize clinical protocols.

Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient.

The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy

Traditional surgical ligation of the spermatic cord veins is effective in reducing the size of the varicocele and improving fertility outcomes. However, this procedure can be associated with complications such as hydrocele formation and recurrence . Antegrade sclerotherapy offers a minimally invasive alternative, involving the injection of a sclerosing agent directly into the dilated veins to achieve occlusion and reduce reflux . This study aims to optimize treatment outcomes for varicocele by combining the benefits of surgical ligation with the sclerosing effects of sclerotherapy .The primary goal is to evaluate the efficacy and safety of combining antegrade sclerotherapy and surgical ligation in the treatment of varicocele .