目的:在男性先天性低促性腺激素性性腺功能减退症(CHH)中,观察到较低剂量的人促性腺激素(hCG)可以维持正常的睾丸内睾酮(ITT)水平。我们建议这项研究来比较低剂量hCG,卵泡刺激素(FSH),和睾酮(T)[LFT方案]常规治疗以诱导男性化和生育能力。
方法:这项开放标签随机试点研究于2020年6月至2021年12月进行。
方法:CHH被随机分配到LFT方案(A组)-低剂量hCG(每周500U三次),FSH(每周150U三次)和T(每两周100mg)或常规治疗(GroupB),高hCG剂量(每周2000U三次)和相同的FSH剂量。在A组和B组中,滴定hCG剂量以将抗苗勒管激素(AMH)降低50%,并使血浆T正常化。分别。主要目的是比较两组之间实现精子发生的个体百分比。
结果:在30名患者中,23名(76·7%)受试者实现了精子发生,中位时间为12(9-14·9)个月。两组之间在精子发生方面没有差异(64·3%vs87·5%,p=0·204),甚至精子发生的中位时间也相似(15个月对12个月,p=0·248)。两组精子发生时血浆AMH中位数均无统计学意义,[6·6ng/ml(3·3-9·76)vs4·41ng/ml(2·3-6·47),p=0·298]。同样,两组之间精子发生时血浆抑制素B的中位数相当[152·4pg/ml(101·7-198·0)vs149·1pg/ml(128·7-237·3),p=0·488]。
结论:诱导男性CHH生育的合理方法是使用FSH开始联合治疗,低剂量hCG靶向AMH<6·9ng/ml,随着T达到正常范围。监测AMH可以作为精子发生的替代指标。
OBJECTIVE: In male congenital hypogonadotropic hypogonadism (CHH), it was observed that lower dose human gonadotropic hormone (hCG) can maintain normal intratesticular testosterone levels. We propose this study to compare the low-dose hCG, follicle stimulating hormone (FSH), and Testosterone (T) [LFT Regimen] to conventional treatment to induce virilization and fertility.
METHODS: This open-label randomized pilot study was conducted from June 2020 to December 2021.
METHODS: CHH were randomly assigned to either the LFT regimen (Group A)-low-dose hCG (500U thrice per week), FSH (150U thrice per week), and T(100 mg biweekly) or conventional therapy(GroupB) with high hCG dose(2000U thrice per week) and the same FSH dose. The hCG dosage was titrated to reduce anti-mullerian hormone (AMH) by 50% and normalization of plasma T in groups A and B, respectively. The primary objective was to compare the percentage of individuals who achieved spermatogenesis between the two groups.
RESULTS: Out of 30 patients, 23 (76·7%) subjects achieved spermatogenesis, and the median time was 12 (9-14·9) months. There was no difference in achieving spermatogenesis between the two groups (64·3% vs 7·5%,P = 0·204), and even the median time for spermatogenesis was similar (15months vs 12months,P = 0·248). Both groups had nonsignificant median plasma AMH at spermatogenesis, [6·6 ng/ml (3·3-9·76) vs4·41 ng/ml (2·3-6·47), P = 0·298]. Similarly, the median plasma Inhibin B at spermatogenesis between groups were comparable [152·4 pg/ml (101·7-198·0) vs49·1 pg/ml (128·7-237·3), P = 0·488].
CONCLUSIONS: A reasonable approach to induce fertility in male CHH is to initiate combination therapy using FSH, low-dose hCG targeting AMH <6·9 ng/ml, along with T to achieve normal range. Monitoring AMH could serve as a proxy indicator of spermatogenesis.