跳至主要内容
临床试验/NCT05503862
NCT05503862
已完成
不适用

Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive

Northwestern University2 个研究点 分布在 1 个国家目标入组 200 人2022年9月9日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Male Infertility
发起方
Northwestern University
入组人数
200
试验地点
2
主要终点
Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
状态
已完成
最后更新
上个月

概览

简要总结

The overall objective of the proposed study is to enhance early detection of male factor infertility and reduce cost and morbidity associated with delayed diagnosis through development of a universal screening model based on home semen testing. The advent of inexpensive and accurate home semen testing has enabled a potential paradigm shift in the approach to male fertility evaluation. The investigator's central hypothesis is that universal home semen testing prior to attempts to conceive is easy for participants and can lead to reduced fertility-related anxiety and early detection of male factor infertility, thereby expediting evaluation and treatment for the couple while minimizing unnecessary cost and morbidity.

This study is specifically designed to assess the feasibility and utility of home semen testing for couples who are beginning attempts to conceive. First, the investigator will assess participants' ability to complete the home semen testing, ease of use, and obstacles encountered in doing so. Second, the investigator will examine the impact of home semen testing in fertility-related quality of life among couples beginning attempts to conceive, as well as ability of home semen testing to increase the diagnosis and treatment of male infertility in these couples.

注册库
clinicaltrials.gov
开始日期
2022年9月9日
结束日期
2025年10月16日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Principal Investigator
主要研究者

Joshua Halpern

Assistant Professor, Department of Urology

Northwestern University

入排标准

入选标准

  • Natal males over the age of 18 with no prior children who are interested in future fertility
  • Current female partner
  • Not attempting to conceive for more than 3 months
  • Willing to sign the Informed Consent Form
  • Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
  • Ownership or accessibility of a smart phone or electronic device that is compatible with the YoSperm® device

排除标准

  • Prior semen testing
  • History of male infertility, Klinefelter syndrome, undescended testis, or chemotherapy
  • Female partner with history of infertility
  • Female partner with irregular menstrual periods

结局指标

主要结局

Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.

时间窗: 12 months

To evaluate the participant's fertility over the course of the study.

Was the home semen testing completed- yes/no?

时间窗: At Day 0 post randomization

To assess if participants randomized to the home semen testing utilize the YoSperm device to complete the home semen testing.

Change in fertility-related World Health organization-5 Well-Being Index (WHO-5).

时间窗: 12 months

To assess participant well-being over the course of the study.

Change in fertility-related Fertility Quality of Life Questionnaire (FertiQoL)

时间窗: 12 months

To assess participant's fertility quality of life over the course of the study.

研究点 (2)

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