Preliminary Results of Microsurgical Testicular Exploration for Sperm Retrieval in Azoospermic Patients: A Randomized Controlled Trial Comparing Operating Microscope vs. Surgical Loupes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Histology
研究概览
简要总结
The aim of the study is to compare surgical outcomes (intra and post-operative complications) and sperm retrieval rates between conventional microsurgical-assisted testicular sperm extraction (m-TeSE - Group A) and testicular sperm extraction performed with surgical loupes (l-TeSE - Group B) in adult males with non-obstructive azoospermia.
详细描述
Objective
To compare surgical outcomes and sperm retrieval rates (SRR) between conventional microsurgical-assisted testicular sperm extraction (m-TeSE - Group A) and testicular sperm extraction performed with surgical loupes (l-TeSE - Group B) in adult males with non-obstructive azoospermia (NOA). A multicentric prospective randomized trial was conducted from March 2022. Adult males with NOA without genetic alterations who agreed to participate in the study and signed the required informed consent were enrolled. SRR, intra and post-operative complications (according to Clavien-Dindo classification), hormonal profile tchanges were considered as outcomes during the follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult males
- •Diagnosis of non obstructive azoospermia who required m-TeSE.
排除标准
- •Absence of signed written informed consent
- •Age < 18 years
- •Obstructive azoospermia
- •Genetic anomalies (e.g., Klinefelter syndrome, Kallmann syndrome, Y chromosome microdeletions, CFTR mutations)
- •Previous testicular biopsies/surgical sperm retrieval
- •Personal history of malignant testicular tumor
- •Unilateral cryptorchidism
- •Varicocele
- •Previous chemotherapy/radiotherapy treatments
- •Monorchidism
结局指标
主要结局
Histology
时间窗: immediately after the surgery
Normal testicular biopsy or Hypospermatogenesis or Germ cell arrest or Sertoli cell-only syndrome or Seminiferous tubule hyalinization or CIS or Immature testis
Positive sperm retrieval
时间窗: immediately after the surgery
Number of sperm retrieval
Johnsen score
时间窗: immediately after the surgery
Number according to Johnsen score
Sperm vials stored
时间窗: immediately after the surgery
Number
次要结局
- Operative time(immediately after the surgery)
- Complications(through study completion, an average of 1 year)
研究者
Mirko Preto
Doctor Mirko Preto
A.O.U. Città della Salute e della Scienza