The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Semen Volume
研究概览
简要总结
This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies.
Participants will:
- Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
- Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory.
- Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels.
During the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.
详细描述
Study participants will:
- Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
- Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory.
- Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels.
During the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form (or assent)
- •Male and age greater than 18 years and less than 50 years of age with a confirmed diagnosis of SMA at the time of signing the Informed Consent Form (or assent)
- •Currently not on a disease-modifying agent or therapy for SMA
- •Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate in the study.
排除标准
- •Men with a prior history of chemotherapy, radiation therapy, prostate or testicular cancer, undescended testicles and use of anabolic steroids or testosterone usage will be excluded
结局指标
主要结局
Semen Volume
时间窗: Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
Home collected semen ejaculates will be obtained to measure semen volume (normal \> 1.5ml)
Sperm Concentration
时间窗: Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
Home collected semen ejaculates will be obtained to measure sperm concentration ( normal \> 15 million sperm/ml)
Sperm Motility
时间窗: Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
Home collected semen ejaculates will be obtained to measure sperm motility ( normal \> 39% motile sperm)
Sperm DNA Fragmentation Assay
时间窗: At intial 3 month study enrollment
Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal \< 30% DNA fragmented sperm)
Sperm Morphology
时间窗: Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
Home collected semen ejaculates will be obtained to measure sperm morphology (normal \> 4% normal sperm morphology)
次要结局
- Male Reproductive Hormones - Estradiol(At intial 3 month study enrollment)
- Male Reproductive Hormones - Total Testosterone Level(At intial 3 month study enrollment)
- Male Reproductive Hormones - Free Testosterone Level(At intial 3 month study enrollment)
- Male Reproductive Hormones - Follicle Stimulating Hormone(At intial 3 month study enrollment)
- Male Reproductive Hormones - Luteinizing Hormone(At intial 3 month study enrollment)