意大利特发性不孕夫妇中男性使用促卵泡激素的情况：一项多中心、观察性、临床实践调查的结果。

Use of follicle-stimulating hormone for the male partner of idiopathic infertile couples in Italy: Results from a multicentre, observational, clinical practice survey.

机构信息

Unità di Endocrinologia, Dipartimento di Scienze Biomediche, Metaboliche e Neuroscienze, Università di Modena e Reggio Emilia, Modena, Italy.

Unità di Endocrinologia, Dipartimento di Specialità Mediche, Azienda Ospedaliero-Universitaria of Modena, Modena, Italy.

出版信息

Andrology. 2020 May;8(3):637-644. doi: 10.1111/andr.12748. Epub 2020 Jan 7.

DOI:10.1111/andr.12748

PMID:31872967

Abstract

BACKGROUND

The management of male idiopathic infertility is heterogeneous. Although meta-analyses reported the effectiveness on pregnancy rate, the real clinical impact of follicle-stimulating hormone (FSH) was not evaluated so far. In Italy, FSH is approved by the National Medicines Agency (AIFA) for idiopathic infertile patients with FSH < 8 IU/L, independently of semen parameters.

AIM

Primary endpoint was to record the therapeutic approach to the male partner of infertile couples. Secondary aim was to assess changes of semen parameters during FSH treatment.

METHODS

A multicentre, prospective, observational, clinical practice survey was carried out, enrolling the male partner of infertile couples attending ten Italian participating centres. Inclusion criteria were as follows: couple infertility, age >18 years and FSH serum levels <8 IU/L. Thus, all men in which AIFA allowed the FSH prescription were enrolled. Primary endpoint was the number of infertile patients treated with FSH. Secondary outcomes were semen parameters. The treating physician decided whether to offer FSH therapy and whether to re-evaluate the male partner.

RESULTS

A total of 718 infertile couples were enrolled, and 241 patients were re-evaluated (median follow-up: 4.5 months). In 64.9% (466 patients), a treatment was prescribed. FSH was prescribed in 397 patients (85.2% of treated men). Sperm concentration (P = .002) and normal form percentage (P < .001) significantly improved during FSH administration. No correlation was found between these parameters and FSH duration (P = .545 and P = .627, respectively) or dosage (P = .455 and P = .533, respectively). Among patients treated with FSH, the incidence of oligozoospermia decreased from 73.0% to 56.0% (P < .001) and teratozoospermia from 43.6% to 27.7% (P < .001).

DISCUSSION

This first nation-wide survey reveals a FSH prescription rate of 55% in patients qualifying for treatment according to AIFA. Although the study was not designed to highlight FSH efficacy in male infertility, a slight increase in semen parameters was demonstrated in about half of the treated men without adverse events.

摘要

背景

男性特发性不育症的治疗方法存在差异。虽然荟萃分析报告了妊娠率的有效性，但迄今为止尚未评估卵泡刺激素（FSH）的实际临床影响。在意大利，国家药品管理局（AIFA）批准 FSH 用于 FSH<8 IU/L 的特发性不孕患者，无论精液参数如何。

目的

主要终点是记录不孕夫妇中男性伴侣的治疗方法。次要目的是评估 FSH 治疗期间精液参数的变化。

方法

进行了一项多中心、前瞻性、观察性、临床实践调查，纳入了 10 个意大利参与中心就诊的不孕夫妇中的男性伴侣。纳入标准如下：夫妇不孕、年龄>18 岁和血清 FSH 水平<8 IU/L。因此，所有符合 AIFA 允许 FSH 处方的男性均被纳入。主要终点是接受 FSH 治疗的不孕患者人数。次要结局是精液参数。治疗医生决定是否提供 FSH 治疗以及是否重新评估男性伴侣。

结果

共纳入 718 对不孕夫妇，241 例患者接受了重新评估（中位随访时间：4.5 个月）。在 64.9%（466 例）的患者中开具了治疗方案。在 397 例（接受治疗男性的 85.2%）患者中开具了 FSH。FSH 给药期间精子浓度（P=0.002）和正常形态百分比（P<0.001）显著改善。这些参数与 FSH 持续时间（P=0.545 和 P=0.627，分别）或剂量（P=0.455 和 P=0.533，分别）之间无相关性。在接受 FSH 治疗的患者中，少精子症的发生率从 73.0%降至 56.0%（P<0.001），畸形精子症的发生率从 43.6%降至 27.7%（P<0.001）。