Maribyrnong

This trial investigates the safety and effectiveness of the Plan A Male Contraceptive System, which temporarily blocks sperm passage by occluding the vas deferens and can later be reversed to restore sperm flow. It is a prospective, multicenter, single-arm, open-label interventional study involving healthy male adults aged 25 to 65. The study focuses on evaluating this device-based contraception method as an alternative to vasectomy. Participants will receive the Plan A occlusion device (Vasalgel) delivered via the Delivery Lumen Access Device. The study has two groups: Group 1 with 30 men will be followed up to 6 months after occlusion or until azoospermia (no sperm in semen) is achieved, after which they may have a vasectomy. Group 2 includes 10 men who, after reaching azoospermia, will undergo a reversal procedure with the Plan A Reversal Device and be followed for up to 3 additional months or until semen returns to baseline, then may have a vasectomy. During the study, participants will provide semen samples and undergo assessments to measure achievement of azoospermia, return to baseline semen levels, and histology analysis up to approximately 9 months. Safety will be monitored from screening through a 14-day follow-up after the last procedure, including adverse events and participant comfort. The study involves careful tracking of semen quality and safety outcomes to evaluate the contraceptive system's performance.