跳至主要内容
临床试验/NCT07546435
NCT07546435招募中不适用

Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality - Have Anything Changed the Past 15 Years?

Peter Humaidan1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Change in patient-experience when compared to the 2008 study conducted at The University Clinic for Fertility, Regional Hospital Skive by using the same questionaire

研究概览

简要总结

Several international studies indicate that men with reduced semen quality often feel overlooked in the context of fertility treatment. Men who undergo fertility treatment due to their own infertility, exhibit increased concern and experience more negative emotions such as loss, stigmatization, and low self-esteem - more so than men undergoing fertility treatment for other reasons.

Since 2008, there has been limited research on the experiences of male patients with infertility in Denmark. Furthermore, there is generally very little knowledge regarding the testosterone levels (hypogonadism) of male infertile patients and its association with quality of life. Thus, there is a lack of updated insight into how infertile men experience their situation today. Additionally, the present study finds it relevant to examine whether men's needs and experiences in interactions with health professionals have changed over the past 15 years.

研究设计

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

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

  • ICSI treatment caused by reduced semen quality, language (danish)

排除标准

  • PESA/TESA, Cancer, Sterilized males

研究组 & 干预措施

Fertile males

Males normal semen quality according to WHO 2021 6th edition

Infertile males

Males with reduced semen quality according to WHO 2021 6th edition

结局指标

主要结局

Change in patient-experience when compared to the 2008 study conducted at The University Clinic for Fertility, Regional Hospital Skive by using the same questionaire

时间窗: From the start of fertility treatment to registration of pregnancy test

Correlation between male serum testosterone level and quality of life evaluated from questionnaire

时间窗: From the start of fertility treatment to registration of pregnancy test

Questionnaire of male experience of involvement in fertility treatment

时间窗: From the start of fertility treatment to registration of pregnancy test

次要结局

  • Questionnarie about the prevalence of psychological and social burden i fertility treatment(From the start of fertility treatment to registration of pregnancy test)
  • A comparison between men with reduced semen quality and men without reduced semen quality focusing on the prevalence of psychological and social burden, desire to communicate with health professionals, and serum testosterone level and life quality(From the start of fertility treatment to registration of pregnancy test)
  • Classification of the examined population into APHRODITE groups(From the start of fertility treatment to end of study)

研究者

发起方
Peter Humaidan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter Humaidan

Professor

Regionshospitalet Viborg, Skive

研究点 (1)

Loading locations...

相似试验