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显微睾丸精子提取术与多次经皮睾丸精子抽吸术治疗非梗阻性无精子症的随机临床试验。

Microdissection Testicular Sperm Extraction Versus Multiple Needle-pass Percutaneous Testicular Sperm Aspiration in Men with Nonobstructive Azoospermia: A Randomized Clinical Trial.

机构信息

Department of Urology, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

Department of Urology, University of Michigan, Ann Arbor, MI, USA.

出版信息

Eur Urol. 2022 Oct;82(4):377-384. doi: 10.1016/j.eururo.2022.04.030. Epub 2022 May 20.

Abstract

BACKGROUND

Surgical extraction of testicular spermatozoa is needed in men with nonobstructive azoospermia (NOA) who wish to become biological fathers. Based on available uncontrolled studies with unspecific patient selection, microdissection testicular sperm extraction (mTESE), having a sperm retrieval rate (SRR) of 50%, is considered the most efficient sperm retrieval procedure. However, no randomized clinical trials for comparison of different sperm retrieval procedures exist. Testicular sperm aspiration (TESA) is simple and commonly used, and we hypothesized that this technique using multiple needle passes would give similar SRRs to mTESE.

OBJECTIVE

To compare mTESE and multiple needle-pass TESA in men with NOA.

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was performed between June 2017 and April 2021, with inclusion of 100 men with NOA from four centers in Denmark and Sweden. All participants received treatment at the same institution.

INTERVENTION

Participants were randomized to mTESE (n = 49) or multiple needle-pass TESA (n = 51). Patients with failed multiple needle-pass TESA proceeded directly to salvage mTESE.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary outcome was SRR. Secondary outcomes included complications and changes in reproductive hormones after surgery.

RESULTS AND LIMITATIONS

Spermatozoa were retrieved in 21/49 (43%) men after mTESE and in 11/51 (22%) men after multiple needle-pass TESA (rate difference -0.21; 95% confidence interval -0.39 to -0.03; p = 0.02). The combined SRR for multiple needle-pass TESA + salvage mTESE was 15/51 (29%). No complications occurred after multiple needle-pass TESA only, while 5/89 (6%) men having mTESE experienced a complication requiring surgical intervention. Overall, no statistically significant differences in reproductive hormones were observed between groups after 6 mo. Limitations include the low number of patients in secondary outcome data.

CONCLUSIONS

In direct comparison, SRR was higher in mTESE than in multiple needle-pass TESA.

PATIENT SUMMARY

Men with azoospermia need surgical extraction of spermatozoa to become biological fathers. In this randomized trial, we compared two surgeries (microdissection testicular sperm extraction [mTESE] and testicular sperm aspiration [TESA]) and found that mTESE gives a higher sperm retrieval rate than multiple needle-pass TESA.

摘要

背景

对于希望成为生物学父亲的非梗阻性无精子症(NOA)男性,需要进行外科睾丸精子提取。基于现有非特异性患者选择的非对照研究,显微睾丸精子提取(mTESE)的精子回收率(SRR)为 50%,被认为是最有效的精子提取程序。然而,目前尚不存在比较不同精子提取程序的随机临床试验。睾丸精子抽吸(TESA)简单且常用,我们假设这种多次穿刺针技术会产生与 mTESE 相似的 SRR。

目的

比较 mTESE 和多次穿刺针 TESA 在 NOA 男性中的应用。

设计、设置和参与者:这是一项 2017 年 6 月至 2021 年 4 月在丹麦和瑞典的四个中心进行的随机临床试验,纳入了 100 名 NOA 男性。所有参与者均在同一机构接受治疗。

干预措施

参与者被随机分配至 mTESE(n=49)或多次穿刺针 TESA(n=51)组。多次穿刺针 TESA 失败的患者直接进行挽救性 mTESE。

主要结局和次要结局

主要结局为 SRR。次要结局包括手术相关并发症和生殖激素的变化。

结果和局限性

mTESE 后有 21/49(43%)名男性和多次穿刺针 TESA 后有 11/51(22%)名男性成功提取精子(率差-0.21;95%置信区间-0.39 至-0.03;p=0.02)。多次穿刺针 TESA+挽救性 mTESE 的总 SRR 为 15/51(29%)。仅进行多次穿刺针 TESA 后无并发症发生,而 mTESE 后有 5/89(6%)名男性发生需要手术干预的并发症。两组患者在 6 个月后,生殖激素均未见统计学显著差异。局限性包括次要结局数据中患者数量较少。

结论

直接比较显示,mTESE 的 SRR 高于多次穿刺针 TESA。

患者总结

无精子症男性需要外科提取精子才能成为生物学父亲。在这项随机试验中,我们比较了两种手术(显微睾丸精子提取[mTESE]和睾丸精子抽吸[TESA]),发现 mTESE 的精子提取率高于多次穿刺针 TESA。

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