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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.
Fertility is defined as the potential to achieve pregnancy naturally. Infertility, on the other hand, is defined as the inability to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse. Infertility negatively affects individuals' quality of life and has implications for societal demographics. In developed countries, infertility is an important social problem, with approximately 15% of couples unable to achieve pregnancy within one year. About 25% of infertility cases are attributed solely to male factors, while 30-40% involve both male and female factors. Overall, in roughly half of couples unable to conceive, the primary cause of infertility is of male origin. When examining male-related causes, varicocele has been shown to be the most common cause of both primary and secondary infertility. Moreover, this condition is considered the most common correctable cause of infertility. Surgical treatment is regarded as the gold standard in correcting varicocele. However, not every individual diagnosed with varicocele is suitable for surgery, and in many cases, follow-up is preferred until deterioration or progression in sperm parameters is observed.
Varicocele is a vascular pathology characterized by abnormal dilatation of the pampiniform plexus veins within the spermatic cord and venous reflux, which can show progressive features. Clinical and experimental studies reveal that multifactorial mechanisms such as venous valve insufficiency, increased hydrostatic pressure, elevated renal vein pressure, impaired testicular microcirculation, and oxidative stress play a role in the development of varicocele. Chronic elevation of intra-abdominal pressure, considered one of the predisposing factors of this disease, affects its progression. Increased intra-abdominal pressure can hinder venous return and contribute to stasis in the testicular venous system, potentially triggering varicocele pathogenesis. Chronic intra-abdominal pressure elevation may be associated with heavy lifting, prolonged straining, and certain postural dysfunctions. Impaired testicular venous drainage can disrupt testicular parenchymal temperature regulation, leading to increased scrotal temperature and adversely affecting spermatogenesis.
According to data published by TÜİK in May 2025, the total fertility rate in Turkey has recently fallen below 2.1, the level required for population replacement, highlighting risks for demographic sustainability. The decline in population growth may lead, in the long term, to a reduced proportion of working-age population, increased burden on the social security system, and negative effects on economic productivity. In this context, supporting reproductive health is of strategic importance not only individually but also socially and economically. Another negative aspect of infertility is the financial burden of its treatment. Assisted reproductive technologies such as in vitro fertilization (IVF), commonly used in infertility treatment, incur high costs at each stage and are often applied multiple times, as reported in the literature. This situation creates a significant economic burden both for individuals and public health expenditures. In Turkey, spending on infertility treatments has been increasing, highlighting the growing need for cost-effective and early intervention approaches.
Osteopathy is a discipline that addresses the interaction between structure and function in a holistic approach, aiming to support the body's self-healing mechanisms. According to osteopathic theory, for internal organs to maintain their physiological functions properly, they must possess mobility and motility compatible with surrounding tissues. This perspective challenges the conventional notion that a disease is limited to the tissue where it appears and has increased awareness in modern medicine that the human body should be considered as a whole. When varicocele pathology is examined from this perspective, the abdominal cavity is regarded as a dynamic hydraulic system, and any factor disrupting the pressure balance within this system may lead to functional impairments in anatomically related organs.
In light of these findings, studies have been reviewed: a meta-analysis examined the effects of osteopathic manual therapy techniques on the symptoms of endometriosis in women and found low to moderate levels of evidence. It was also reported that limited participant numbers and lack of control groups could lead to misleading evidence. Another study applied thoracic diaphragm release, pelvic and urogenital diaphragm release, pubococcygeal ligament release, and mobilization of the uterus and surrounding organs in women with endometriosis, resulting in significantly improved quality of life. However, similar studies in male subjects are extremely limited.
The originality of our study stems from the fact that although male factors contribute to approximately half of infertility cases, research on conservative and complementary approaches in this field is almost nonexistent. While the literature contains various studies on female infertility and pelvic organ function using manual and complementary therapy approaches, similar research in male infertility, particularly in the context of varicocele management, is extremely limited. In this regard, the project aims to fill a significant gap in the literature and to be the first systematic study focusing on the regulation of intra-abdominal pressure and the support of pelvic organ functions in the management of varicocele.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visceral Osteopathic Massage Group | Experimental | Participants in this group will receive visceral osteopathic massage techniques. |
|
| Control Group | No Intervention | This group will only be given physical activity recommendations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and at the end of 8 weeks |
| Respiratory Pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik Lokman Hekim Hospital, Clinic of Urology | Ankara | Keçiören | 06300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 39941438 | 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. | |
| 22588748 |
| Label | URL |
|---|---|
| World Health Organization. (2023). Infertility fact sheet. | View source |
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Individual participant data will not be shared to ensure participant confidentiality. No personally identifiable information (such as full names or ID numbers) will be collected or stored. All data will be anonymized and used only for collective statistical analysis within the scope of this study.
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| ID | Term |
|---|---|
| D014646 | Varicocele |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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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.
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|
Assessment of chest expansion at axillary, subcostal, and epigastric levels. |
| Baseline and at the end of 8 weeks. |
| Background |
| Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 21733620 | Background | 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. |
| 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 |
| 26752853 | 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. |
| 29452579 | 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. |
| 40687657 | 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. |
| 35052192 | 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. |
| 16140336 | 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. |
| 23905708 | 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. |
| 17182703 | 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. |
| 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 |
| 26780872 | 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. |
| 23940419 | Background | 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. |
| Türkiye İstatistik Kurumu. "Doğum istatistikleri, 2024". | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |