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.