About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, age 20-40 years
Diagnosis of infertility (primary or secondary)
History of at least one unsuccessful embryo transfer
Disqualifiers
Contraindications to spa treatment
Acute gynecological inflammation
Severe comorbidities affecting study outcomes
Oncological disease
Trial design
Single group
Treatments tested in this trial
Comrehensive Spa Treatment (KLP)
Procedure/SurgeryA 21-day comprehensive spa treatment program including balneotherapy, peloid therapy, physiotherapy, and lifestyle interventions.
Treatment groups
Trial outcomes
Primary outcomes
Change in hormonal profile
Change in serum levels of LH, FSH, prolactin, estradiol, progesterone, testosterone, and AMH between baseline and end of treatment.
Secondary outcomes
Perceived stress (PSS-10)
Change in Perceived Stress Scale-10 total score (range 0 to 40; higher scores indicate greater perceived stress).
Quality of life (EQ-5D-5L)
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
Occurrence of pregnancy, method of conception (natural conception or assisted reproduction), and pregnancy outcome (ongoing pregnancy, live birth, miscarriage).
Body composition
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).
Sponsors and contacts
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Institute of Spa and Balneology, public research institution
Lead sponsor
Františkovy lázně
Collaborator