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

NCT07542600 | Not Yet Recruiting

• 1 other identifier: INF_431/23
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Female Infertility; Reproductive Disorders; Recurrent Pregnancy Loss

Keywords

Spa Treatment; Balneotherapy; Female Infertility; Hormonal Profile; IVF Preparation

Outcome Measures

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.

  Baseline to end of treatment (21 days)

Secondary Outcomes (4)

• Perceived stress (PSS-10)

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

• Quality of life (EQ-5D-5L)

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

• Pregnancy outcomes

  Assessed at 6 months and 12 months after completion of treatment

• Body composition

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

Study Arms (1)

Comprehensive Spa Treatment (KLP)

EXPERIMENTAL

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)

Interventions

Comrehensive Spa Treatment (KLP) PROCEDURE

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

Comprehensive Spa Treatment (KLP)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Eligibility is limited to biological females due to the study focus on female reproductive physiology, including hormonal profile, ovarian function, and endometrial parameters related to infertility.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, age 20-40 years
• Diagnosis of infertility (primary or secondary)
• History of at least one unsuccessful embryo transfer

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Spa and Balneology, public research institution: lead
• Františkovy lázně: collaborator

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 21, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04