Female Infertility, Recurrent Pregnancy Loss, Reproductive Disorders
Conditions
Keywords
Spa Treatment, Balneotherapy, Female Infertility, Hormonal Profile, IVF Preparation
Brief summary
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.
Detailed description
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. The treatment includes: * peloid therapy (peat applications, vaginal tampons) * mineral water procedures (baths, vaginal irrigations) * carbon dioxide therapy * physiotherapy (including Mojžíšová method) * exercise therapy and rehabilitation * dietotherapy and lifestyle education Each patient undergoes a standardized spa treatment program prescribed individually by a physician. ASSESSMENT SCHEDULE: All assessments are performed at two time points: * baseline (no later than day 3 after admission) * end of treatment (day 19-21) Measured parameters: * hormonal profile (LH, FSH, prolactin, estradiol, progesterone, testosterone, AMH) * ultrasound examination (folliculometry, endometrial thickness)\[MV3.1\] * physical examination * questionnaire-based assessments: * PSS-10 (Perceived Stress Scale) * EQ-5D-5L (quality of life) * FertiQoL * BAS 2 FOLLOW-UP: Participants will be contacted at: * 6 months after treatment * 12 months after treatment Collected data (questionnaire): * pregnancy occurrence * method of conception (spontaneous vs assisted reproduction) * pregnancy outcome (e.g., miscarriage, live birth) Participants may also be asked to complete follow-up questionnaires (PSS-10 and EQ-5D-5L), depending on feasibility. DATA MANAGEMENT: All patient data are pseudonymized using unique ID codes assigned at enrollment. Data are collected in both paper and electronic form. Paper records are stored in individual binders organized by patient ID. Data handling complies with EU General Data Protection Regulation (GDPR, Regulation 2016/679) and Good Clinical Practice principles. ILaB is responsible for the final statistical analysis and interpretation of the collected data. ETHICAL CONSIDERATIONS: The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen (reference no. 431/23, approved on November 2, 2023). All participants provide written informed consent before enrollment. The study procedures represent minimal risk and correspond to standard clinical practice.
Interventions
PROCEDUREComrehensive Spa Treatment (KLP)
A 21-day comprehensive spa treatment program including balneotherapy, peloid therapy, physiotherapy, and lifestyle interventions.
Sponsors
Institute of Spa and Balneology, public research institution
Františkovy lázně
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Female, age 20-40 years * Diagnosis of infertility (primary or secondary) * History of at least one unsuccessful embryo transfer
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hormonal profile | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress (PSS-10) | Baseline (Day 1) and end of treatment (Day 21) | Change in Perceived Stress Scale-10 total score (range 0 to 40; higher scores indicate greater perceived stress). |
| Quality of life (EQ-5D-5L) | Baseline (Day 1) and end of treatment (Day 21) | Change in EQ-5D-5L health-related quality of life index score and EQ Visual Analogue Scale score (VAS 0 to 100; higher scores indicate better perceived health). |
| Pregnancy outcomes | Assessed at 6 months and 12 months after completion of treatment | Occurrence of pregnancy, method of conception (natural conception or assisted reproduction), and pregnancy outcome (ongoing pregnancy, live birth, miscarriage). |
| Body composition | Baseline (Day 1) and end of treatment (Day 21) | Change in body composition parameters including body fat mass, skeletal muscle mass, fat-free mass, and total body water measured using bioelectrical impedance analysis (InBody). |
Countries
Czechia
Outcome results
None listed