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Clinical Trials in Turkey / NCT07665905
Starting soon Not applicable

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

NCT07665905 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-06-24

Condition(s) studied

VaricoceleInfertility

Investigational drug(s) / intervention(s)

Visceral Osteopathic Massage Techiques

Visceral Osteopathic Massage Techiques: Thoracic Diaphragm Release: Patient supine; therapist applies gentle pressure under the costal arch during expiration to enhance diaphragmatic mobility and regulate intra-abdominal pressure. Renal Vein \& Sigmoid Colon Mobilization: Manual oscillatory pressure is applied to abdominal organs following their natural motility to reduce fascial restrictions and support vascular/lymphatic flow. Indirect Inguinal Canal Release: Tissues are held in a position of least tension for up to one minute to induce relaxation, reducing pelvic floor tension and regulating pressure. Obturator Internus Release: Uses muscle energy or indirect approaches. After passive stretch and isometric contraction, post-isometric relaxation is utilized to achieve a painless state. Great Abdominal Maneuver: Rhythmic manual pressures in harmony with breathing are applied to the abdominal wall to boost venous and lymphatic circulation. Bladder \& Rectum Mobilization: Gentle manual techniques to regulate pelvic floor.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male individuals aged 18-45 years. 2. Diagnosis of varicocele confirmed by clinical examination and Doppler Ultrasound. 3. Not being considered a candidate for surgery by a urology specialist. 4. Following a follow-up protocol based on spermiogram results. 5. Having at least one varicocele-related abnormality in spermiogram parameters according to WHO 2021 standards. 6. Providing voluntary consent to participate in the study. Exclusion Criteria: 1. History of prior inguinal or scrotal surgery. 2. Presence of active urogenital infection or malignancy. 3. History of spinal or abdominal surgery that would contraindicate complementary medicine interventions. 4. Having systemic inflammatory, rheumatologic, or endocrinologic diseases. 5. Receiving additional medical or surgical intervention during the study period beyond routine medical treatment. 6. Sperm quality changes due to hypogonadotropic causes. 7. Use of prescribed purified flavonoid fraction venotonics for venous congestion and endothelial dysfunction. 8. Use of antioxidant supplements (e.g., L-carnitine, L-acetylcarnitine, Ubiquinol, etc.) intended to improve sperm quality. 9. Refusal to participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Etlik Lokman Hekim Hospital, Clinic of Urology Ankara Keçiören

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07665905 on ClinicalTrials.gov ↗ ← All trials in Turkey