Objective Assessment of the Effect of Comprehensive Spa Rehabilitation Care on Female Infertility: A Prospective Interventional Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in hormonal profile
研究概览
简要总结
This is a prospective, single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa treatment (Komplexní lázeňská léčebně rehabilitační péče, KLP) on female infertility at spa facility in Františkovy Lázně, Czech Republic.
The study enrolls 55 women aged 20-40 years diagnosed with infertility. The primary objective is to assess changes in hormonal profile before and after treatment.
Secondary objectives include evaluation of body composition, psychometric outcomes and long-term reproductive outcomes.
详细描述
STUDY DESIGN AND SETTING:
This is a prospective, single-arm interventional study using a one-group pretest-posttest design conducted at a spa facility in Františkovy Lázně, Czech Republic.
The study evaluates the effects of standard comprehensive spa treatment on women with infertility. The treatment is provided as part of routine clinical care covered by health insurance. The study does not modify the treatment protocol and only collects clinical data before and after treatment.
INTERVENTION:
The intervention is a standard 21-day comprehensive spa treatment program (KLP) based on natural healing resources of Františkovy Lázně.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 20-40 years
- •Diagnosis of infertility (primary or secondary)
- •History of at least one unsuccessful embryo transfer
排除标准
- •Contraindications to spa treatment
- •Acute gynecological inflammation
- •Severe comorbidities affecting study outcomes
- •Oncological disease
- •Alcohol intake >20 g/day
- •Non-compliance with treatment
- •Diagnosed with endometriosis
研究组 & 干预措施
Comprehensive Spa Treatment (KLP)
Women with infertility undergoing standard 21-day comprehensive spa treatment program in Františkovy Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Comrehensive Spa Treatment (KLP) (Procedure)
结局指标
主要结局
Change in hormonal profile
时间窗: Baseline to end of treatment (21 days)
Change in serum levels of LH, FSH, prolactin, estradiol, progesterone, testosterone, and AMH between baseline and end of treatment.
次要结局
- Perceived stress (PSS-10)(Baseline (Day 1) and end of treatment (Day 21))
- Quality of life (EQ-5D-5L)(Baseline (Day 1) and end of treatment (Day 21))
- Pregnancy outcomes(Assessed at 6 months and 12 months after completion of treatment)
- Body composition(Baseline (Day 1) and end of treatment (Day 21))