A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization.

Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487), IVD-B (n = 485) or NSV (n = 487) groups and underwent operation. Follow-up included visits at the 3 rd -6 th and 12 th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations) and semen analysis. The subjects' partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV) among the three groups (P > 0.05). The cumulative rates of complications at the 12 th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.

[Long-term effect and safety of non-occlusive intra-vas device for male contraception].

OBJECTIVE: To assess the long-term effect and safety of non-occlusive intra-vas device (IVD) for male contraception in comparison with no-scalpel vasectomy (NSV). METHODS: We conducted a follow-up investigation on 100 males who had received IVD and another 50 who had undergone NSV 6 years before. We compared the rates of sperm absence and complications between the two groups. RESULTS: Follow-up visits were successfully performed on 95 males (95%) of the IVD group and 44 (88%) of the NSV group. Pregnancy was not found in any of the cases. Spermatozoa (> or = 5 x 10(6)/ml) were not detected in 87 cases (91.58%) in the IVD group and in 44 cases (95.45%) in the NSV group, with no significant differences between the two groups (P > 0.05). The rate of postoperative complications in the IVD group (11.58%) showed no significant difference from that of the NSV group (4.55%) (P > 0.05). CONCLUSION: IVD is as effective and safe as NSV for male contraception.

[Epidemiological study on semen quality of 562 volunteers aged 22-30].

OBJECTIVE: This study is to understand the difference of semen quality among the different areas and the related factors. METHODS: Five hundred and sixty-two people were under from seven provinces. RESULTS: Results showed that the quantity and density of semen, the rate of moving forward semen, livability, percent age of normal formed semen and the total number of semen were statistically different among the seven areas. The difference was ranged as 28.82%, with the highest 2.95 ml in Shanxi province and the lowest 2.29 ml in Henan province. Geometric mean of semen density was found the lowest 36.27 x 10(6)/ml in Guizhou province, next to it was 42.52 x 10(6)/ml in Shandong province and the highest was 74.77 x 10(6)/ml in Hebei province. The percent age with forward progression of semen was seen the lowest 44.40% in Henan province, followed by 51.88% in Hebei province and 52.88% in Zhejiang province and the highest were 76.50% in Shanghai, 75.24% in Shanxi province, with a range of 72.30%. The highest semen viability was 85.89% in Shanghai, while the lowest 72.35% in Henan, with a range of 18.71%. Normal sperm morphology was seen the lowest 68.45% in Hebei province, with the highest 88.06% in Guizhou province, and the range was 28.65%. The geometric mean of total sperm count was seen the highest 204.23 x 10(6)/ml in Hebei province and the lowest 77.69 x 10(6)/ml in Guizhou province. Results showed through analysis of variance that some indexes were different in some provinces. CONCLUSION: The results indicated that the semen quality was different in different regions in China and its influential factors may be region and geography environment.