Acupuncture for Vasectomy

Overseen By Amanda J Crawford, BA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Matthew Snyder

Must not be taking: Chronic pain meds, Benzodiazepines, Anxiolytics

Disqualifiers: Repeat vasectomy, Anxiety, Phobias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupuncture can reduce anxiety and pain before and during a vasectomy, compared to standard medications. Participants will receive either acupuncture (a form of Traditional Chinese Medicine) or the usual pre-procedure medications to determine which is more effective. Men scheduled for a vasectomy and able to receive care at Nellis Air Force Base may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore alternative pain management options.

Will I have to stop taking my current medications?

The trial requires that participants do not use chronic pain medications, benzodiazepines (a type of medication often used for anxiety), or current anxiolytic medications (medications that reduce anxiety). If you are taking these, you would need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that acupuncture is generally safe for people. A review of studies involving over 2,400 participants found that acupuncture reduced osteoarthritis pain more effectively than no treatment, indicating it is well-tolerated. Another study examined acupuncture's impact on various types of pain, demonstrating its effectiveness and safety. Although acupuncture is not a new treatment, its application in areas such as managing pain and anxiety before a vasectomy remains under investigation. Overall, evidence suggests acupuncture is a low-risk option with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard vasectomy procedures that typically rely on medications for pain management, this approach incorporates acupuncture, an ancient practice known for its potential to alleviate pain and reduce anxiety. Researchers are excited about this trial because acupuncture offers a non-pharmacological alternative that might enhance comfort and recovery without the side effects associated with medications. By potentially reducing reliance on standard pre-procedure medications, acupuncture could offer a more holistic and patient-friendly experience.

What evidence suggests that this trial's treatments could be effective for improving pre-procedural anxiety and procedural pain relief in vasectomy patients?

Research has shown that acupuncture, one of the treatments studied in this trial, can help manage pain and anxiety. Studies have found that it improves symptoms in various conditions by promoting relaxation and reducing stress. For example, acupuncture improved the quality of life for patients with chronic heart failure by alleviating symptoms more effectively than no treatment. Although specific research on acupuncture for vasectomy is limited, its success in easing stress and pain in other medical contexts suggests potential benefits here as well. Acupuncture is known to enhance overall well-being, which could reduce anxiety and discomfort before and during medical procedures like a vasectomy. Participants in this trial may receive either acupuncture or the clinic's standardized pre-procedure medications alone. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for male active duty members and DoD beneficiaries, aged 25 or older, who are scheduled for a vasectomy at Nellis Air Force Base. It's not open to those with blood/injury phobia, anxiety disorders, needle shock history, on anxiolytics or chronic pain meds, or with past vasovagal responses.

Inclusion Criteria

I am scheduled for a vasectomy.

I am a male over 25 years old and either active duty or a DoD beneficiary.

Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study

Exclusion Criteria

You have a history of fainting in response to certain triggers.

You have a fear of blood or getting injured.

I am currently taking medication for anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-procedure

Participants receive either acupuncture or standardized pre-procedure medications to manage anxiety and pain before vasectomy

1 day

1 visit (in-person)

Procedure

Participants undergo the vasectomy procedure

1 day

1 visit (in-person)

Post-procedure

Participants' pain and anxiety are measured immediately after the procedure

1 day

Follow-up

Participants are monitored for pain and anxiety, and complete a satisfaction survey 2-4 days post-procedure

2 weeks

1 visit (in-person), diary entries

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture
• Standardized pre-procedure medications

Trial Overview The study is testing if auricular (ear) acupuncture and body acupuncture following the Koffman protocol can better manage pre-procedural anxiety and pain during a vasectomy compared to standard pre-procedure medications given in clinics.

How Is the Trial Designed?

Group I: Acupuncture Experimental Treatment 1 Intervention

Acupuncture

Group II: Standardized pre-procedure medications Active Control 1 Intervention

The clinic standardized pre-procedure medications alone

Acupuncture is already approved in United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

Matthew Snyder

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

Fascial interposition during vasectomy significantly reduces the likelihood of vasectomy failure, although it may lead to more surgical difficulties; however, side effects were similar between techniques.

The intra-vas device was found to be less effective in achieving azoospermia compared to no-scalpel vasectomy, but it resulted in higher satisfaction among men, indicating a trade-off between effectiveness and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasectomy occlusion techniques for male sterilization. Cook, LA., Van Vliet, H., Lopez, LM., et al.[2020]

A systematic review of 115 Chinese-language articles identified 479 cases of adverse events related to acupuncture, with 14 reported deaths, highlighting significant safety concerns.

The most common adverse events included pneumothorax and infections, primarily resulting from improper techniques, indicating a need for improved monitoring and risk management in acupuncture practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. Zhang, J., Shang, H., Gao, X., et al.[2022]

The review found that current studies comparing vasectomy techniques, such as vas occlusion and vas irrigation, are of poor quality and do not provide conclusive evidence on their effectiveness or safety.

Fascial interposition during vasectomy may improve the likelihood of achieving azoospermia (no sperm in semen) but is also linked to increased surgical difficulties, indicating a trade-off between effectiveness and ease of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasectomy occlusion techniques for male sterilization. Cook, LA., Vliet, H., Pun, A., et al.[2018]

A systematic review of 37 studies on electroacupuncture (EA) identified various adverse events (AEs), with common issues including pallor, skin pigmentation, and vertigo, highlighting the need for awareness of these potential side effects in clinical practice.

While most patients (62%) fully recovered from AEs related to EA, there were serious incidents reported, including three deaths, indicating that although EA can be beneficial, it carries risks that require careful monitoring and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to electroacupuncture: a systematic review of single case studies and case series. Park, JH., Lee, JH., Lee, S., et al.[2021]

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

A new vasectomy technique developed in China since 1974 uses a scalpel-free method that results in fewer complications, such as hematomas (0.09% incidence in 179,741 men) and infections, while leaving a smaller, non-visible wound that requires no sutures.

The procedure is quick, taking only 5 to 11 minutes, and has shown promising results in the U.S. with no complications in the first 273 surgeries performed, suggesting it could improve the safety and acceptance of vasectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The no-scalpel vasectomy. Li, SQ., Goldstein, M., Zhu, J., et al.[2022]

Fascial interposition during vasectomy significantly reduces the likelihood of vasectomy failure, although it may lead to more surgical difficulties; however, side effects were similar between groups.

The intra-vas device was found to be less effective in achieving azoospermia compared to no-scalpel vasectomy, but it resulted in higher satisfaction among men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasectomy occlusion techniques for male sterilization. Cook, LA., Van Vliet, HA., Lopez, LM., et al.[2021]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

A study involving 150 men showed that percutaneous no-scalpel vasectomy (NSV) via one puncture is a quick procedure, averaging only 9.8 minutes, and allows for complete recovery in about 8.5 days.

The modified NSV technique demonstrated an extremely low complication rate of just 0.67%, indicating it is a safe and effective method for permanent contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous no-scalpel vasectomy via one puncture in China. Li, L., Shao, J., Wang, X.[2020]

In a study involving 1968 patients across three multicenter randomized controlled trials, only 3.76% experienced adverse events from acupuncture, indicating a low risk associated with this therapy.

The most common adverse events were minor, such as subcutaneous haematoma and needle site pain, and all but one patient recovered within two weeks, suggesting acupuncture is generally safe when performed by skilled practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Zhao, L., Zhang, FW., Li, Y., et al.[2021]

Acupuncture was found to significantly improve sperm motility and concentration in infertile men, with mean differences indicating better outcomes compared to control groups, although the studies showed high levels of variability.

Despite these improvements in semen quality, acupuncture did not lead to a significant increase in pregnancy rates, and the overall evidence is considered insufficient due to the small number of studies and concerns about bias and reporting quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of acupuncture for poor semen quality in infertile males: a systematic review and meta-analysis. Jerng, UM., Jo, JY., Lee, S., et al.[2021]

In a study of 22 men with idiopathic infertility, acupuncture treatment for 8 weeks significantly improved quick sperm motility from 11.0% to 18.3% and increased the normal sperm ratio from 16.2% to 21.1%.

Following acupuncture, the fertilization rates in assisted reproductive technology (ICSI) rose dramatically from 40.2% to 66.2%, indicating that acupuncture may enhance sperm quality and improve outcomes in fertility treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of acupuncture on idiopathic male infertility in assisted reproductive technology. Zhang, M., Huang, G., Lu, F., et al.[2019]

Acupuncture treatment significantly improved sperm concentration more than varicocelectomy in a study of 30 men with primary infertility and varicocele, suggesting it may be an effective alternative therapy.

Both acupuncture and varicocelectomy resulted in similar pregnancy rates of 33% after treatment, indicating that acupuncture can be a viable option for improving fertility in men with semen abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial of comparing effects of acupuncture and varicocelectomy on sperm parameters in infertile varicocele patients. Kucuk, EV., Bindayi, A., Boylu, U., et al.[2017]

A 41-year-old male with severe oligoasthenoteratozoospermia (OAT) underwent 28 sessions of manual acupuncture, which significantly improved his sperm motility from 25% to 67% after two treatment series.

The results suggest that manual acupuncture, when combined with medication, can effectively enhance male fertility, particularly in improving sperm motility, leading to a change in diagnosis from severe OAT to severe oligoteratozoospermia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture Therapy for Severe Oligoasthenoteratozoospermia. Nareswari, I., Lestari, SW., Notonegoro, C.[2022]

Acupuncture has been shown to significantly increase serum testosterone levels and improve semen quality in men with oligoasthenozoospermia by enhancing spermatogenesis and testicular blood flow.

Despite these promising effects, the overall quality of clinical studies on acupuncture for this condition is low, indicating that more rigorous research is needed to confirm its efficacy and clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acupuncture treatment of oligoasthenozoospermia]. Li, J., Wu, XK., Zhang, JX.[2018]

Citations

1. withpower.com withpower.com/trial/acupuncture-for-vasectomy-ece3e

Acupuncture for Vasectomy · Info for Participants In a study of 22 men with idiopathic infertility, acupuncture treatment for 8 weeks significantly improved quick sperm motility from 11.0% to 18.3% and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9624472/

The efficacy and mechanism of acupuncture in the treatment ... The results showed that the percentage of motile sperm in the acupuncture arm is significantly higher than that in the placebo arm, which ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02098928

Comparison Between Hand-acupuncture and Electro ... Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause. ClinicalTrials.gov ID NCT02098928.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559979/

Effectiveness of electroacupuncture and acupuncture in ... This study demonstrated that EA and AC are effective in alleviating the symptoms of CHHF and enhancing the quality of life compared to no treatment.

5. scirp.org scirp.org/journal/paperinformation?paperid=123750

Meta-Analysis of the Clinical Efficacy of Acupuncture in ... Based on current evidence, acupuncture is more effective than Western medicine (prednisone) alone in the treatment of male immune infertility.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663860/

Effectiveness and safety of acupuncture combined with ... Clinical studies have found that acupuncture combined with traditional Chinese medicine (TCM) has achieved good results in treating CP, but its efficacy and ...

7. esmed.org esmed.org/MRA/mra/article/view/6871

Efficacy, Safety and Mechanisms of Acupuncture and ... Research into the efficacy and safety of acupuncture and electroacupuncture for the relief of various types of pain, as well as the ...

8. nccih.nih.gov nccih.nih.gov/health/acupuncture-effectiveness-and-safety

Acupuncture: Effectiveness and Safety - nccIH.nih.gov In a 2018 review, data from 10 studies (2,413 participants) showed acupuncture was more effective than no treatment for osteoarthritis pain, and data from 9 ...