Optimising Preconceptual Health in Subfertile PCOS Patients. Implementation of a Lifestyle Modification Program Before Fertility Treatment, Impact on Health Related Quality of Life and Obstetric Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- body composition
研究概览
简要总结
Patients will be randomly assigned to a group where they undergo a 12-week lifestyle modification program prior to their fertility treatment, or a group where they are entitled to start their fertility treatment without prior lifestyle modification program.
详细描述
When allocated to the control arm patients will receive the standard of care combined with the foreseen questionnaires and bio-electric impedance analysis for body composition and ergospirometry. When the patient is allocated to the interventional arm she will receive a 12-week lifestyle modification program prior to her fertility treatment. The lifestyle modification program will consist of dietary advice, advice for physical activity and emotional support. After the 12-week program the fertilty treatment will start as per routine practice. Questionnaires, ergospirometry and bio-electric impedance analysis will also be performed at the foreseen moments.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subfertile patients between >18- <38 years old requesting fertility treatment at our centre
- •PCOS phenotypes A, B, C and D according to the NIH 2012 extension of the ESHRE/ASRM 2003 diagnostic criteria
- •BMI >27 and <38 (Jiskoot et al. 2017)
- •Nulliparous women
- •Patient gives consent voluntarily
排除标准
- •Patients will be excluded if they:
- •do not meet the ESHRE/ASRM 2003 diagnostic PCOS criteria
- •Have a BMI <27 and >38 (Jiskoot et al. 2017)
- •Need Surgical sperm retrieval
- •Use donor eggs
- •Need Pre-implantation genetic testing (PGT)
- •Multiparous women
- •cannot reliably fill out the questionnaires or comprehend the intervention, because of a language barrier
研究组 & 干预措施
Standard-of-care group
No intervention
Lifestyle intervention group
12-week lifestyle modification programme through face-to-face lifestyle counseling and physiotherapy combined with a follow-up programme using video consultations and online training sessions
干预措施: Lifestyle program (Behavioral)
结局指标
主要结局
body composition
时间窗: 12 weeks after start of intervention
body composition (Total Body Fat and Fat Free Mass), measured by using bio-electric im-pedance analysis (BIA)
body weight
时间窗: 12 weeks after start of intervention
body weight (kg)
次要结局
未报告次要终点