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

NCT07665905 | Not Yet Recruiting

• 1 other identifier: BA_VARICOCELE_03/126
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicocele; Infertility

Keywords

Osteopathic Physicians; Varicocele; Infertility; Men's Health

Outcome Measures

Primary Outcomes (6)

• Semen Parameters

  Evaluation of liquefaction time

  Baseline and at the end of 8 weeks.

• Semen Parameters

  progressive motility (%)

  Baseline and at the end of 8 weeks.

• Semen Parameters

  non-progressive motility (%)

  Baseline and at the end of 8 weeks.

• Semen Parameters

  immotility (%)

  Baseline and at the end of 8 weeks.

• Venous Hemodynamics

  Pampiniform plexus vein diameter

  Baseline and at the end of 8 weeks.

• Venous Hemodynamics

  Venous Reflux Peak Velocity Duration

  Baseline and at the end of 8 weeks.

Secondary Outcomes (2)

• Pain Intensity (VAS)

  Baseline and at the end of 8 weeks

• Respiratory Pattern

  Baseline and at the end of 8 weeks.

Study Arms (2)

Visceral Osteopathic Massage Group

EXPERIMENTAL

Participants in this group will receive visceral osteopathic massage techniques.

Other: Visceral Osteopathic Massage Techiques

Control Group

NO INTERVENTION

This group will only be given physical activity recommendations.

Interventions

Visceral Osteopathic Massage Techiques OTHER

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.

Visceral Osteopathic Massage Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Having at least one varicocele-related abnormality in spermiogram parameters according to WHO 2021 standards.
• Providing voluntary consent to participate in the study.

You may not qualify if:

• 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.
• Receiving additional medical or surgical intervention during the study period beyond routine medical treatment.
• Sperm quality changes due to hypogonadotropic causes.
• Use of prescribed purified flavonoid fraction venotonics for venous congestion and endothelial dysfunction.
• Use of antioxidant supplements (e.g., L-carnitine, L-acetylcarnitine, Ubiquinol, etc.) intended to improve sperm quality.
• Refusal to participate in the study.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Etlik Lokman Hekim Hospital, Clinic of Urology

Ankara, Keçiören, 06300, Turkey (Türkiye)

Location

Related Publications (19)

• Courtney, R. (2009). The functions of breathing and its dysfunctions and their relationship to breathing therapy. International Journal of Osteopathic Medicine, 12(3), 78-85. https://doi.org/10.1016/j.ijosm.2009.04.002

  BACKGROUND

• Wojcik M, Kampioni M, Hudakova Z, Siatkowski I, Kedzia W, Jarzabek-Bielecka G. The Effect of Osteopathic Visceral Manipulation on Quality of Life and Postural Stability in Women with Endometriosis and Women with Pelvic Organ Prolapse: A Non-Controlled Before-After Clinical Study. J Clin Med. 2025 Jan 24;14(3):767. doi: 10.3390/jcm14030767.

  PMID: 39941438 BACKGROUND

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• Baazeem A, Belzile E, Ciampi A, Dohle G, Jarvi K, Salonia A, Weidner W, Zini A. Varicocele and male factor infertility treatment: a new meta-analysis and review of the role of varicocele repair. Eur Urol. 2011 Oct;60(4):796-808. doi: 10.1016/j.eururo.2011.06.018. Epub 2011 Jul 5.

  PMID: 21733620 BACKGROUND

• Kuchera, M. L., & Kuchera, W. A. (1994). Osteopathic principles in practice (2nd ed.). Greyden Press.

  BACKGROUND

• Chaitow, L. (2013). Muscle energy techniques (4th ed.). Churchill Livingstone.

  BACKGROUND

• Jones, L. H., Kusunose, R., & Goering, E. K. (1995). Strain and counterstrain. Jones Strain-Counterstrain Inc.

  BACKGROUND

• Barral, J. P. (2007). Visceral osteopathy. Eastland Press.

  BACKGROUND

• De Strooper, M., De Nys, L., Theys, L., Vermeersch, A., & Quaghebeur, J. (2024). Osteopathic manual treatment in women with endometriosis: A scoping review on clinical symptoms, fertility and quality of life. International Journal of Osteopathic Medicine, 54, Article 100733. https://doi.org/10.1016/j.ijosm.2024.100733

  BACKGROUND

• Kumar N, Singh AK. Trends of male factor infertility, an important cause of infertility: A review of literature. J Hum Reprod Sci. 2015 Oct-Dec;8(4):191-6. doi: 10.4103/0974-1208.170370.

  PMID: 26752853 BACKGROUND

• Guillaud A, Darbois N, Monvoisin R, Pinsault N. Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review. BMC Complement Altern Med. 2018 Feb 17;18(1):65. doi: 10.1186/s12906-018-2098-8.

  PMID: 29452579 BACKGROUND

• Shi S, Chen W, Tian J, Liang Z, Wu J, Li J, Li L, Zhang F. Risk factors associated with varicocele: a narrative review. Transl Androl Urol. 2025 Jun 30;14(6):1807-1817. doi: 10.21037/tau-2025-120. Epub 2025 Jun 26.

  PMID: 40687657 BACKGROUND

• Tramontano M, Tamburella F, Dal Farra F, Bergna A, Lunghi C, Innocenti M, Cavera F, Savini F, Manzo V, D'Alessandro G. International Overview of Somatic Dysfunction Assessment and Treatment in Osteopathic Research: A Scoping Review. Healthcare (Basel). 2021 Dec 24;10(1):28. doi: 10.3390/healthcare10010028.

  PMID: 35052192 BACKGROUND

• Cobb WS, Burns JM, Kercher KW, Matthews BD, James Norton H, Todd Heniford B. Normal intraabdominal pressure in healthy adults. J Surg Res. 2005 Dec;129(2):231-5. doi: 10.1016/j.jss.2005.06.015. Epub 2005 Sep 2.

  PMID: 16140336 BACKGROUND

• Chambers GM, Adamson GD, Eijkemans MJ. Acceptable cost for the patient and society. Fertil Steril. 2013 Aug;100(2):319-27. doi: 10.1016/j.fertnstert.2013.06.017.

  PMID: 23905708 BACKGROUND

• Turgut AT, Ozden E, Kosar P, Kosar U, Cakal B, Karabulut A. Chronic constipation as a causative factor for development of varicocele in men: a prospective ultrasonographic study. J Ultrasound Med. 2007 Jan;26(1):5-10. doi: 10.7863/jum.2007.26.1.5.

  PMID: 17182703 BACKGROUND

• Aşçı, R., & Açıkgöz, A. (2012). Varikosel: İnsidans, etiyoloji ve fizyopatoloji. Turkiye Klinikleri J Urology-Special Topics, 5(3), 6-15. https://www.turkiyeklinikleri.com/article/tr-varikosel-insidans-etiyoloji-ve-fizyopatoloji-63172.html

  BACKGROUND

• Agarwal A, Sharma R, Harlev A, Esteves SC. Effect of varicocele on semen characteristics according to the new 2010 World Health Organization criteria: a systematic review and meta-analysis. Asian J Androl. 2016 Mar-Apr;18(2):163-70. doi: 10.4103/1008-682X.172638.

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• Bordoni B, Zanier E. Anatomic connections of the diaphragm: influence of respiration on the body system. J Multidiscip Healthc. 2013 Jul 25;6:281-91. doi: 10.2147/JMDH.S45443. Print 2013.

  PMID: 23940419 BACKGROUND

Related Links

• World Health Organization. (2023). Infertility fact sheet.
• Türkiye İstatistik Kurumu. "Doğum istatistikleri, 2024".

MeSH Terms

Conditions

Varicocele; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: Participants will be randomized into two groups: intervention and control. The intervention group will receive visceral osteopathic massage (VOM) techniques twice a week for 8 weeks, while the control group will receive physical activity recommendations. Assessments will be performed at baseline and repeated after the 8-week period. Pain will be evaluated using the Visual Analog Scale (VAS) during the morning, evening, and the most strenuous activity. Respiratory pattern assessments will include measurements at the axillary, subcostal, and epigastric levels. Semen parameters (liquefaction time, progressive motility, non-progressive motility, and immotility) will be analyzed. Furthermore, hemodynamic assessment will include the diameter of the pampiniform plexus veins and venous reflux peak velocity duration.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)