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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAnkara Yildirim Beyazıt University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male individuals aged 18-45 years.

Diagnosis of varicocele confirmed by clinical examination and Doppler Ultrasound.

Not being considered a candidate for surgery by a urology specialist.

Following a follow-up protocol based on spermiogram results.

Disqualifiers

History of prior inguinal or scrotal surgery.

Presence of active urogenital infection or malignancy.

History of spinal or abdominal surgery that would contraindicate complementary medicine interventions.

Having systemic inflammatory, rheumatologic, or endocrinologic diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Visceral Osteopathic Massage Techiques

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Visceral Osteopathic Massage GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Semen Parameters

Evaluation of liquefaction time

Time frame
Baseline and at the end of 8 weeks.
2

Semen Parameters

progressive motility (%)

Time frame
Baseline and at the end of 8 weeks.
3

Semen Parameters

non-progressive motility (%)

Time frame
Baseline and at the end of 8 weeks.
4

Semen Parameters

immotility (%)

Time frame
Baseline and at the end of 8 weeks.

Secondary outcomes

1

Pain Intensity (VAS)

Pain levels will be assessed using the Visual Analog Scale (VAS) during the morning, evening, and the most strenuous activity. (Scale: 0 = no pain, 10 = worst possible pain).

Time frame
Baseline and at the end of 8 weeks
2

Respiratory Pattern

Assessment of chest expansion at axillary, subcostal, and epigastric levels.

Time frame
Baseline and at the end of 8 weeks.

Other outcomes

Sponsors and contacts

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