Effect of Comprehensive Spa Rehabilitation on Female Infertility: A Clinical Study in Adult Women (Infertility-Spa)

April 17, 2026 updated by: Institute of Spa and Balneology, public research institution

Objective Assessment of the Effect of Comprehensive Spa Rehabilitation Care on Female Infertility: A Prospective Interventional Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Comrehensive Spa Treatment (KLP)
A 21-day comprehensive spa treatment program including balneotherapy, peloid therapy, physiotherapy, and lifestyle interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hormonal profile
Time Frame: 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.
Baseline to end of treatment (21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress (PSS-10)
Time Frame: 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).
Baseline (Day 1) and end of treatment (Day 21)
Quality of life (EQ-5D-5L)
Time Frame: 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).
Baseline (Day 1) and end of treatment (Day 21)
Pregnancy outcomes
Time Frame: 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).
Assessed at 6 months and 12 months after completion of treatment
Body composition
Time Frame: 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).
Baseline (Day 1) and end of treatment (Day 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Spa and Balneology, public research institution

Collaborators

Františkovy lázně

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INF_431/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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