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