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临床试验/NCT07286279
NCT07286279尚未招募不适用

Identifying Infertile Men Who May be Amenable to a Limited Testicular Dissection at Microdissection Testicular Sperm Extraction

Clinique Ovo1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
Successful sperm retrieval rate defined as the presence of spermatozoa during limited dissection (mini-incision) micro-TESE

研究概览

简要总结

The goal of this retrospective observational study is to learn whether certain clinical characteristics can help predict which infertile men may successfully have sperm retrieved using a less-invasive "mini-incision" version of micro-TESE. The study focuses on men with very low or absent sperm counts (non-obstructive azoospermia, cryptozoospermia, or severe OAT).

The main questions it aims to answer are:

Can sperm be successfully found using only a small, limited-dissection micro-TESE in some men?

Which clinical factors (such as hormone levels or medical history) help identify men who may benefit from this less-invasive approach?

Researchers will compare men who had successful sperm retrieval with the mini-incision alone to men who required a more extensive micro-TESE to see if certain characteristics predict which approach is likely to work.

详细描述

This retrospective cohort study evaluates whether preoperative clinical characteristics can help identify infertile men who are likely to achieve successful sperm retrieval through a limited-dissection, mini-incision micro-TESE. The stepwise surgical approach begins with a small equatorial incision for targeted micro-biopsies and is expanded only when sperm are not initially identified.

The study includes men who underwent their first micro-TESE at a high-volume fertility center over a 10-year period. All procedures followed a standardized surgical protocol and were performed by a single experienced surgeon, ensuring uniformity in technique.

Clinical data routinely collected before surgery, such as hormone levels, semen parameters, testicular volume, and relevant medical history, were analyzed and compared between men who required only the mini-incision and those who proceeded to an extended dissection. By examining these differences, the study aims to determine whether certain patient characteristics can predict the success with the less-invasive approach.

The findings may help guide pre-surgical counseling and support more tailored surgical planning for men with severe male factor infertility

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with cryptozoospermia or non obstructive azoospermia that underwent a micro-TESE

排除标准

  • Patients with a potentially reversible cause of cryptozoospermia (i.e., presence of a varicocele, febrile illness, or recent toxin exposure)
  • Patients with suspected partial genital tract obstruction (i.e post-vaso-vasostomy, post-vasoepididymostomy, and low volume cryptozoospermia with ejaculatory duct obstruction)
  • Patients who have previously undergone a micro-TESE, TESA or TESE procedure

结局指标

主要结局

Successful sperm retrieval rate defined as the presence of spermatozoa during limited dissection (mini-incision) micro-TESE

时间窗: At the time of limited dissection (mini-incision)

次要结局

  • Genetic abnormalities rate(At baseline)
  • Serum FSH levels(At baseline)
  • Serum testosterone levels(At baseline)
  • Testicular volume(At baseline)
  • Procedure conversion from limited to extensive micro-TESE rate(At the time of limited dissection (mini-incision))

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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