Effect of Combined Low Dose Human Gonadotropic Hormone, Follicle Stimulating Hormone, and Testosterone Therapy (LFT Regimen) Versus Conventional High Dose Human Gonadotropic Hormone and Follicle Stimulating Hormone on Spermatogenesis and Biomarkers in Men With Hypogonadotropic Hypogonadism

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM Endocrine Practice Pub Date : 2024-10-01 DOI:10.1016/j.eprac.2024.07.007

Nikhil Singhania MD , Konsam Biona Devi MD, DM , Japleen Kaur MD , Anil Bhansali MD, DM , Ujjwal Gorsi MD , Naresh Sachdeva PhD , Sunil Arora PhD , Ashutosh Rai PhD , Rama Walia MD, DM

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Abstract

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.

Design

This open-label randomized pilot study was conducted from June 2020 to December 2021.

Subjects and outcome measures

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.

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小剂量 hCG、FSH 和睾酮联合疗法（LFT 方案）与传统的大剂量 hCG 和 FSH 对促性腺激素低下男性精子发生和生物标志物的影响。

研究目的在男性先天性性腺功能减退症(CHH)中，观察到低剂量的人类促性腺激素(hCG)可以维持正常的睾丸内睾酮(ITT)水平。我们建议本研究比较低剂量促性腺激素（hCG）、促卵泡激素（FSH）和睾酮（T）[LFT方案]与常规治疗，以诱导男性化和生育：这项开放标签随机试验研究于2020年6月至2021年12月进行：受试者被随机分配到LFT方案（A组）--低剂量hCG（500U，每周三次）、FSH（150U，每周三次）和T（100mg，每两周一次）或常规治疗（B组）--高剂量hCG（2000U，每周三次）和相同剂量的FSH。A组和B组的hCG剂量分别控制在抗苗勒氏管激素（AMH）降低50%和血浆T正常的水平。主要目的是比较两组实现精子发生的比例：结果：30 名患者中，23 人（76-7%）实现了生精，中位时间为 12（9-14-9）个月。两组患者的生精率没有差异（64-3%vs87-5%，P=0-204），甚至生精的中位时间也相似（15个月vs12个月，P=0-248）。两组患者精子发生时的血浆 AMH 中位数均无显著差异（6-6ng/ml(3-3-9-76) vs 4-41ng/ml(2-3-6-47)，P=0-298）。同样，各组精子发生时的血浆抑制素 B 中位数也相当[152-4pg/ml(101-7-198-0)vs149-1pg/ml(128-7-237-3),p=0-488]：诱导男性CHH生育的合理方法是使用FSH、小剂量hCG和AMH联合治疗。

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来源期刊

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.