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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorInstitute of Spa and Balneology, public research institution

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Comrehensive Spa Treatment (KLP)

    Procedure/Surgery

    A 21-day comprehensive spa treatment program including balneotherapy, peloid therapy, physiotherapy, and lifestyle interventions.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Comprehensive Spa Treatment (KLP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in hormonal profile

Change in serum levels of LH, FSH, prolactin, estradiol, progesterone, testosterone, and AMH between baseline and end of treatment.

Time frame
Baseline to end of treatment (21 days)

Secondary outcomes

1

Perceived stress (PSS-10)

Change in Perceived Stress Scale-10 total score (range 0 to 40; higher scores indicate greater perceived stress).

Time frame
Baseline (Day 1) and end of treatment (Day 21)
2

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).

Time frame
Baseline (Day 1) and end of treatment (Day 21)
3

Pregnancy outcomes

Occurrence of pregnancy, method of conception (natural conception or assisted reproduction), and pregnancy outcome (ongoing pregnancy, live birth, miscarriage).

Time frame
Assessed at 6 months and 12 months after completion of treatment
4

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).

Time frame
Baseline (Day 1) and end of treatment (Day 21)

Other outcomes

Sponsors and contacts

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