Investigating the Physiological Effects of Weight Loss on Male Fertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Sperm Concentration
研究概览
简要总结
The purpose of this study is to determine the physiological effects of weight loss on seminal parameters in male participants with reduced reproductive capacity. Learning more about the physiological role of weight loss on reproductive function and metabolic profile of overweight and obese men may give us a better understanding of male fertility and improve the management of patients with reduced fertility. The effects of weight loss on seminal quality are not well understood.
详细描述
Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 30 kg/m^2 [Part: 1, 2& 3]
- •Evidence of reduced reproductive capacity (e.g. reduced sperm concentration [applicable for study B]
排除标准
- •History of undescended testes, testicular surgery or mumps infection
- •Hormonal therapy such as testosterone or selective oestrogen receptor modulators
- •History of systemic cytotoxic therapy or pelvic radiotherapy
- •Chronic systemic disease, such as cardiac, renal or liver failure
- •At least one of the following:
- •Alcohol intake >30 units per week Smoking daily Recreational drug use at a frequency not less than weekly
- •Acute illness likely to affect the result of study
- •Impaired ability to provide full consent to take part in the study
- •An occupation requiring strenuous physical exercise that may require a high energy diet
结局指标
主要结局
Sperm Concentration
时间窗: 16 weeks
The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis
次要结局
- DNA Fragmentation Index (DFI)(16 weeks)
- Testosterone(16 weeks)
- Sex Hormone-Binding Globulin (SHBG)(16 weeks)
- Luteinizing Hormone (LH)(16 weeks)
- Total Motility(16 weeks)
- Progressive Motility(16 weeks)
- Reactive Oxygen Species (ROS)(16 weeks)
- Morphology(16 weeks)
- Follicle Stimulating Hormone (FSH)(16 weeks)