VaricoceleNCT07665905
Effects of Visceral Osteopathic Massage on Semen Parameters and Hemodynamics Factors in Varicocele
A study testing Visceral Osteopathic Massage Techiques in people with Varicocele and Infertility, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Varicocele, Infertility
- What is being tested?
- Visceral Osteopathic Massage Techiques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Etlik Lokman Hekim Hospital, Clinic of Urology
Ankara, Keçiören, 06300
Bihter Akinoglu, Assoc. Prof. Dr., +905059384136, bakinoglu@aybu.edu.tr
Akif Arda Sari, PT, MSc Student, +905533637894, ftrakifardasari@gmail.com
About this study
Official title: Investigation of the Effects of Visceral Osteopathic Massage Techniques on Semen Parameters and Hemodynamic Factors in Men With Varicocele: A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Varicocele, Infertility
- Being tested
- Visceral Osteopathic Massage Techiques
- Keywords
- Osteopathic Physicians, Varicocele, Infertility, Men's Health
- Medical subject headings
- Varicocele, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral Osteopathic Massage TechiquesOther
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 group | Role | What they receive |
|---|---|---|
| Visceral Osteopathic Massage Group | Experimental | Participants in this group will receive visceral osteopathic massage techniques. Receives: Other: Visceral Osteopathic Massage Techiques |
| Control Group | No intervention | This group will only be given physical activity recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen Parameters
Evaluation of liquefaction time
Measured: Baseline and at the end of 8 weeks.
Semen Parameters
progressive motility (%)
Measured: Baseline and at the end of 8 weeks.
Semen Parameters
non-progressive motility (%)
Measured: Baseline and at the end of 8 weeks.
Semen Parameters
immotility (%)
Measured: Baseline and at the end of 8 weeks.
Venous Hemodynamics
Pampiniform plexus vein diameter
Measured: Baseline and at the end of 8 weeks.
Venous Hemodynamics
Venous Reflux Peak Velocity Duration
Measured: Baseline and at the end of 8 weeks.
Secondary outcomes (2)
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).
Measured: Baseline and at the end of 8 weeks
Respiratory Pattern
Assessment of chest expansion at axillary, subcostal, and epigastric levels.
Measured: Baseline and at the end of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665905
- Sponsor's protocol ID
- BA_VARICOCELE_03/126
- Status last verified
- Jun 2026
- First submitted
- 9 Apr 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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
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.
PubMed 39941438Hawker 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.
PubMed 22588748Baazeem 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.
PubMed 21733620Kuchera, M. L., & Kuchera, W. A. (1994). Osteopathic principles in practice (2nd ed.). Greyden Press.
Chaitow, L. (2013). Muscle energy techniques (4th ed.). Churchill Livingstone.
Jones, L. H., Kusunose, R., & Goering, E. K. (1995). Strain and counterstrain. Jones Strain-Counterstrain Inc.
Barral, J. P. (2007). Visceral osteopathy. Eastland Press.
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
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.
PubMed 26752853Guillaud 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.
PubMed 29452579Shi 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.
PubMed 40687657Tramontano 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.
PubMed 35052192Cobb 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.
PubMed 16140336Chambers 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.
PubMed 23905708
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Visceral Osteopathic Massage Techniques on Semen Parameters and Hemodynamic Factors in Men With Varicocele: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07665905
- Acronym / sponsor ID
- BA_VARICOCELE_03/126
- Conditions
- Varicocele, Infertility
- Keywords
- Osteopathic Physicians, Varicocele, Infertility, Men's Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Visceral Osteopathic Massage Group | Experimental | Other: Visceral Osteopathic Massage TechiquesParticipants in this group will receive visceral osteopathic massage techniques. |
| Control Group | No intervention | –This group will only be given physical activity recommendations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visceral Osteopathic Massage TechiquesThoracic 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. | Other | Visceral Osteopathic Massage Group |
Primary outcome
Semen Parameters
Time frame: Baseline and at the end of 8 weeks.
Evaluation of liquefaction time
Semen Parameters
Time frame: Baseline and at the end of 8 weeks.
progressive motility (%)
Semen Parameters
Time frame: Baseline and at the end of 8 weeks.
non-progressive motility (%)
Semen Parameters
Time frame: Baseline and at the end of 8 weeks.
immotility (%)
Venous Hemodynamics
Time frame: Baseline and at the end of 8 weeks.
Pampiniform plexus vein diameter
Venous Hemodynamics
Time frame: Baseline and at the end of 8 weeks.
Venous Reflux Peak Velocity Duration
2 secondary outcomes
Pain Intensity (VAS)
Time frame: Baseline and at the end of 8 weeks
Respiratory Pattern
Time frame: Baseline and at the end of 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- BackgroundCourtney, 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: PubMed 39941438Wojcik 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.
- Background: PubMed 22588748Hawker 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.
- Background: PubMed 21733620Baazeem 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.
- BackgroundKuchera, M. L., & Kuchera, W. A. (1994). Osteopathic principles in practice (2nd ed.). Greyden Press.
- BackgroundChaitow, L. (2013). Muscle energy techniques (4th ed.). Churchill Livingstone.
- BackgroundJones, L. H., Kusunose, R., & Goering, E. K. (1995). Strain and counterstrain. Jones Strain-Counterstrain Inc.
- BackgroundBarral, J. P. (2007). Visceral osteopathy. Eastland Press.
- BackgroundDe 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: PubMed 26752853Kumar 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.
- Background: PubMed 29452579Guillaud 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.
- Background: PubMed 40687657Shi 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.
- World Health Organization. (2023). Infertility fact sheet.Link provided by the sponsor.
- Türkiye İstatistik Kurumu. "Doğum istatistikleri, 2024".Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Varicocele
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Not yet recruitingObservational study
Internal Spermatic Vein Histopathology in Patients Undergoing Varicocelectomy
Varicocele
Recruiting
Transjugular and Transfemoral Embolization for Varicocele.
Varicocele
Not yet recruiting
Recover@Home Postoperative Follow-up Study
Hernia, Inguinal, Hernia, Femoral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Etlik Lokman Hekim Hospital, Clinic of Urology
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral Osteopathic Massage Techiques in people with Varicocele and Infertility, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen Parameters (time frame: Baseline and at the end of 8 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07665905, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.