Molecular Mechanisms for Male Fertility: Can Diet Change Sperm sncRNA and the Reproductive Potential?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sperm RNA profile changes
研究概览
简要总结
In this study, patients with infertility treated with IVF at the Center of Reproductive Medicine in Linköping, Sweden, will receive recipes and food according to Nordic dietary guidelines. The purpose is to investigate whether a short diet intervention is sufficient to improve sperm quality and shift the small non-coding RNA profile. In our previous study sperm showed rapid response to diet.
详细描述
This study is a randomized controlled trial recruiting males seeking IVF treatment with their female partner at the Center for Reproductive Medicine in Linkoping, Sweden. Men will be randomized to a control group or diet intervention group.
The intervention group will receive groceries with planned recipes during the hormonal treatment period for the woman (11-14 days) before IVF. The meal plan will be according to the Nordic dietary guidelines and individualized to match total energy expenditure.
The male partner must accept to participate in the diet intervention in order to be included and the female partner can choose to participate in the diet intervention but it is optional. Sperm samples will be collected before the start of hormonal treatment and on ovum pick-up day. Weight will be measured before and after the intervention. Sperm samples will be processed as standard practice at the fertility clinic. Sperm samples will be used for molecular analysis, such as small RNA sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 56 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male (biological) partner in infertile couple, scheduled for first IVF treatment
- •Mature sperm cells in semen
- •Able to speak and read Swedish
- •Will refrain from nicotine and alcohol during intervention
- •Sperm sampled provided no more than 3 weeks before intervention start
排除标准
- •Former or present malignant disease
- •Former radiotherapy in pelvic area
- •Former chemotherapy
- •Known genetic/chromosomal disorder
- •Food allergy
结局指标
主要结局
Sperm RNA profile changes
时间窗: At day at ovum pick-up
Small RNA profiling and sequencing will be performed on sperm cells provided by participant at the start of controlled ovarian hormone stimulation of partner and at time of ovum pick-up and compared between the intervention groups.
Sperm total count
时间窗: At day of ovum pick-up
Sperm total count in millions, assessed by sperm analysis
Sperm concentration
时间窗: At day of ovum pick-up
Sperm concentration assessed by sperm analysis in millions/ml, with total sperm count in millions, divided by semen volume assessed in ml.
Sperm sample analysis
时间窗: At day of ovum pick-up
Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent
次要结局
- Fertilization rate(Day one after ovum pick-up)
- High quality embryo rate(Day 6 after ovum pick-up)
- Embryos frozen(Day 5 and/or 6 after ovum pick-up)
- Clinical pregnancy rate(Assessed 5-7 weeks after ovum pick-up)
- Pregnancy rate(Assessed three weeks after ovum pick-up)
研究者
Susanne Liffner
Principal Investigator
Region Östergötland