Plan A male contraceptive system to block and restore sperm flow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm, open-label feasibility trial of the Plan A occlusion and reversal system (Vasalgel delivered via DLAD) in 40 men. All participants will receive the occlusion procedure; 30 men will be followed for up to six months or until azoospermia and then offered standard vasectomy, while 10 men who reach azoospermia will undergo the Plan A reversal procedure and be followed for up to an additional three months or until baseline semen levels return. Semen analysis and safety monitoring will be performed throughout follow-up to document time to azoospermia, reversibility, and adverse events. The trial focuses on procedure feasibility, short-term effectiveness at blocking sperm, and early evidence of reversal ability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
2. Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
3. 25 to 65 years of age at the time of consent
4. Body Mass Index (BMI) \<31 kg/m2
5. Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
6. Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
7. In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
8. Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
9. Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory

Exclusion Criteria:

1. (On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.
2. Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
3. Recurrent pain with ejaculations
4. Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
5. Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection
6. History of prostatitis or benign prostatic hypertrophy requiring treatment
7. Has undergone prior chemotherapy
8. Has known current coagulopathy or other bleeding disorders
9. Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
10. Subjects with cystic fibrosis
11. Subjects with a history of inguinal hernia repair
12. Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
13. Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
14. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
15. In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
16. Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

Where it's running

• Western Urology
  Maribyrnong, Victoria, Australia Recruiting
• Dr. Snip
  St Kilda, Victoria, Australia Recruiting
• Clinique de Vasectomie
  Hawkesbury, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Homi Zargar, MD — Western Urology
• Study coordinator: Darlene Walley R Chief Executive Officer, PhD
• Email: darlene.walley@nextlifesciences.org
• Phone: 1-415-407-5229

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.