Study of Plan A Male Contraceptive System to Block and Reverse Sperm Flow Using a Device for Long-Term Contraception in Men Aged 25 to 65

What this Trial Is About

Researchers are studying the Plan A Male Contraceptive System, designed to block sperm passage by occluding the vas deferens and later reversing this blockage to allow sperm flow again. This prospective, multicenter, single-arm, open-label clinical trial aims to evaluate the safety and effectiveness of this system in healthy adult men aged 25 to 65 who are seeking long-term contraception through vasectomy. The study is supported by Next Life Sciences and involves 40 male participants. Participants are divided into two groups. Group 1, with 30 men, will have the occlusion procedure using the Delivery Lumen Access Device and Vasalgel and will be followed up for up to 6 months or until azoospermia no sperm in semen is confirmed they will then be offered vasectomy. Group 2, including 10 men who reach azoospermia after occlusion, will undergo the reversal procedure with the Plan A Reversal Device and followed for up to 3 additional months or until baseline semen levels return, after which vasectomy will be offered. The trial compares outcomes from occlusion alone and occlusion followed by reversal. Participants will provide semen samples regularly to monitor azoospermia and semen levels, starting at the 30-day follow-up visit. Safety is tracked from screening through a 14-day phone follow-up post-procedure. Researchers will assess adverse events, histology from occlusion until vasectomy, and participant comfort and satisfaction throughout the study. Total participation lasts approximately 9 months, covering occlusion, reversal for Group 2, and follow-up visits.

Plan A Occlusion and Reversal System Feasibility Study