Division of Reproductive Biology, Maternal Health and Child Health, Indian Council of Medical Research, New Delhi, India.
Male Family Planning Clinic, Lok Nayak Jai Parkash Narayan Hospital, Delhi, India.
Indian J Med Res. 2019 Jul;150(1):81-86. doi: 10.4103/ijmr.IJMR_635_18.
BACKGROUND & OBJECTIVES: For improved male contraception, a new polymeric drug molecule - Reversible Inhibition of Sperm under Guidance (RISUG) has been synthesized and has been found to be effective, safe and reversible in various animal species. Phase-I and phase-II clinical trials have confirmed its safety and contraceptive efficacy. The present study was undertaken as a multicentric-limited phase-III clinical trial to test the efficacy and safety of RISUG in human volunteers.
One hundred and thirty nine young males each having at least two children and living with wife were given 120 μl of RISUG as bilateral vas intraluminal injection. After the single-dose administration, the individuals were followed in respect of general health and semen parameters. Their wives were also followed particularly to determine onset of pregnancy.
During the six month follow up, the health of male volunteers and their wives was normal with no significant adverse effects. Temporary scrotal enlargement and mild scrotal and inguinal region pain were manifested in most individuals and resolved within one month without any routine activity impairment. In six individuals, there was injection procedure failure and azoospermia was not achieved. The other 133 individuals had either severe oligozoospermia or azoospermia at the first semen examination one month following RISUG injection; 82.7 per cent individuals had continued azoospermia in the month following first semen examination onwards and the rest 17.3 per cent manifested azoospermia within three to six months.
INTERPRETATION & CONCLUSIONS: RISUG intravasal injection appears to be a safe clinical procedure with no significant adverse effects and has high sustained contraceptive efficacy. The localized intervention and continued contraceptive action on single-dose administration were significant features of the RISUG technology.
为了改进男性避孕方法，一种新的聚合物药物分子——在指导下可逆性精子抑制（RISUG）已经被合成，并在各种动物物种中被证明是有效、安全和可逆的。I 期和 II 期临床试验已经证实了其安全性和避孕效果。本研究是一项多中心有限 III 期临床试验，旨在测试 RISUG 在人类志愿者中的疗效和安全性。
139 名年轻男性，每个男性至少有两个孩子，并与妻子生活在一起，给予 120 μl 的 RISUG 作为双侧输精管内注射。单次给药后，对个体的一般健康和精液参数进行随访。还对他们的妻子进行了随访，特别是为了确定怀孕的开始。
在 6 个月的随访期间，男性志愿者及其妻子的健康状况正常，没有明显的不良反应。大多数人表现出暂时性阴囊肿大和轻度阴囊和腹股沟区域疼痛，一个月内自行缓解，没有任何常规活动受损。在 6 名个体中，存在注射程序失败，未能达到无精子症。其余 133 名个体在 RISUG 注射后一个月的第一次精液检查中要么表现出严重的少精子症要么表现为无精子症；82.7%的个体在第一次精液检查后的一个月内持续无精子症，其余 17.3%的个体在 3 至 6 个月内表现出无精子症。
RISUG 血管内注射似乎是一种安全的临床程序，没有明显的不良反应，具有高持续避孕效果。局部干预和单次给药后的持续避孕作用是 RISUG 技术的显著特征。
