Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Subsequent pursuit of formal male infertility evaluation via the follow-up Fertility Questionnaire.
研究概览
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
- •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
研究组 & 干预措施
Arm A
At home semen testing via the YoSperm device
干预措施: YoSperm (Device)
Arm B
Standard of Care
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.
Number of Participants Who Completed the Home Semen Testing
时间窗: Device mailed to patient immediately following 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 Fertility Quality of Life Questionnaire (FertiQoL)
时间窗: Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2) after baseline.
Fertility Quality of Life (FertiQoL) Core Score. FertiQoL is a measure of fertility-related quality of life. The total score reported in this study was derived from the Emotional, Mind-Body, Relational, and Social domains. Scores range from 0 to 100, with higher scores indicating better fertility-related quality of life and lower scores indicating worse fertility-related quality of life. Unit of measure: scores on a scale. Subscale and total scoring: Scoring consists of three steps. 1. Reverse items. 2. Calculate raw scores by summing all items that belong to the subscale or total scale. For the Core FertiQoL add all 'Q' items (24 items). For the Treatment FertiQoL add all the 'T' items (10 items). For the Total FertiQoL add all Core and Treatment items (34 items). 3. To compute scaled scores for the subscale and total scales, multiply the relevant raw score by 25/k, where k is the number of items in the subscale. The scaled scores range is 0 to 100.
Change in Fertility-related WHO-5 Questionnaire
时间窗: Original occurred at baseline. Short-term F/U: 60-120 days after baseline (Def. 1) or 60-150 days (Def. 2) after baseline; Long-term F/U: 300-425 days after baseline (Def. 1) or 367 to 967 days after baseline (Def. 2)
To assess participant's well-being as it relates to their fertility World Health Organization Five Well-Being Index (WHO-5). The WHO-5 is a 5-item measure of current psychological well-being. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better psychological well-being and lower scores indicating worse psychological well-being. Unit of measure: scores on a scale
次要结局
- Fertility Questionnaire Outcomes at Short-Term Follow-Up (60-120 Days After Baseline) Definition 1(60-120 days after baseline)
- Fertility Questionnaire Outcomes at Short-Term Follow-Up (Definition 2: Between 60 - 150 Days After Baseline)(3 months)
- Fertility Questionnaire Outcomes at Long-Term Follow-Up (Definition 1: 300-425 Days After Baseline) Definition 1(300-425 days)
- Fertility Questionnaire Outcomes at Long-Term Follow-Up Definition 2(367 to 967 days after baseline)
- Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 1(60-120 days after baseline)
- Fertility Questionnaire: Participant Length of Attempting to Conceive Short Term F/U Definition 2(60-150 days after baseline)
- Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 1(300-425 days after baseline)
- Fertility Questionnaire: Participant Length of Attempting to Conceive Long Term F/U Definition 2(367 to 967 days after baseline)
研究者
Joshua Halpern
Assistant Professor, Department of Urology
Northwestern University