Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- CD56 endometrial NK cell function
研究概览
简要总结
In 50% of women with recurrent pregnancy loss (RPL) miscarriages are unexplained, therefore no therapeutic intervention is possible. In a pilot study, women with unexplained RPL showed less endometrial NK cells (eNK) compared to women with a previously uncomplicated pregnancy. It is known that eNK cells are important for embryo implantation during early pregnancy. Investigators presume that high sympathetic activity in these women is related to eNK cell number, function and phenotype and that exercise is an effective intervention to lower sympathetic activity and to influence the immune system, as especially peripheral NK cells have been assumed to be responsive to physical training. The investigators hypothesize that moderate exercise can lower the adrenergic tone of the sympathetic nervous system hereby influencing endometrial NK cells in women with RPL and eventually pregnancy outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •RPL defined as 2 or more unexplained pregnancy losses from the time of conception until 24 weeks of gestation, known cause for the miscarriages are the presence of thyroid abnormalities, anti-phospholipid syndrome, uterine malformation, and abnormal parental karyotype according to international guideline.
- •Couples should not be aiming to conceive during the time course of the exercise intervention.
排除标准
- •Age above 40 years
- •BMI above 40
- •Current use of immunosuppressive or biological drugs
- •Current use of hormone conceptive
- •HIV positivity
- •Current or recent (<2 weeks) symptomatic genital infection such as chlamydia, gonorroa, or pelvic inflammatory disease
- •Pre-existent diabetes mellitus, autoimmune disease or overt cardiovascular disease
- •Vaccination (i.e Covid) within 1 month prior to or during sampling and intervention
- •New pregnancy at time of measurements, breastfeeding
- •Current or recent (<2-3 months ago) pregnancy
- •(Physical) inabilities to follow moderate aerobe cycling training
- •Participants who are not capable of signing the informed consent
结局指标
主要结局
CD56 endometrial NK cell function
时间窗: 3 months
Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry.
CD56 endometrial NK cell frequency
时间窗: 3 months
Change in CD56 eNK cell frequency measured as percentage of total lymphocyte or total CD56 population by flowcytometry.
次要结局
- Metabolic syndrome parameters I(3 months)
- Physical fitness(3 months)
- CD56 peripheral NK cell frequency(3 months)
- CD56 endometrial NK cell phenotype(3 months)
- CD56 peripheral NK cell function(3 months)
- CD56 peripheral NK cell phenotype(3 months)
- Metabolic syndrome parameters III(3 months)
- Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome.(3 months)
- Vaginal microbiome(3 months)
- Metabolic syndrome parameters II(3 months)
- Metabolic syndrome parameters IV(3 months)
- Metabolic syndrome parameters V(3 months)
- Sympathetic activity(3 months)
- Uterine blood flow(3 months)
研究者
Tess Meuleman
Principal Investigator
Radboud University Medical Center