Female InfertilityNCT07542600
Effect of Comprehensive Spa Rehabilitation on Female Infertility: A Clinical Study in Adult Women (Infertility-Spa)
A study testing Comrehensive Spa Treatment (KLP) in people with Female Infertility and Reproductive Disorders, run by Institute of Spa and Balneology, public research institution at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Female Infertility, Reproductive Disorders, Recurrent Pregnancy Loss
- What is being tested?
- Comrehensive Spa Treatment (KLP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Apr 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, age 20-40 years
- Diagnosis of infertility (primary or secondary)
- History of at least one unsuccessful embryo transfer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Spa Resort Pawlik-Aquaforum
Františkovy Lázně, Carlsbad Region, 35101
Edita Šimáčková, +420 724 163 127, edita.simackova@fla.cz
About this study
Official title: 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.
Read the 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.
- Being tested
- Comrehensive Spa Treatment (KLP)
- Keywords
- Spa Treatment, Balneotherapy, Female Infertility, Hormonal Profile, IVF Preparation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comrehensive Spa Treatment (KLP)Procedure or surgery
A 21-day comprehensive spa treatment program including balneotherapy, peloid therapy, physiotherapy, and lifestyle interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Comrehensive Spa Treatment (KLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hormonal profile
Change in serum levels of LH, FSH, prolactin, estradiol, progesterone, testosterone, and AMH between baseline and end of treatment.
Measured: Baseline to end of treatment (21 days)
Secondary outcomes (4)
Perceived stress (PSS-10)
Change in Perceived Stress Scale-10 total score (range 0 to 40; higher scores indicate greater perceived stress).
Measured: Baseline (Day 1) and end of treatment (Day 21)
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).
Measured: Baseline (Day 1) and end of treatment (Day 21)
Pregnancy outcomes
Occurrence of pregnancy, method of conception (natural conception or assisted reproduction), and pregnancy outcome (ongoing pregnancy, live birth, miscarriage).
Measured: Assessed at 6 months and 12 months after completion of treatment
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).
Measured: Baseline (Day 1) and end of treatment (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Apr 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Spa and Balneology, public research institution
- Sponsor type
- University, hospital or other
- Collaborators
- Františkovy lázně
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542600
- Sponsor's protocol ID
- INF_431/23
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of the Effect of Comprehensive Spa Rehabilitation Care on Female Infertility: A Prospective Interventional Clinical Study
- ClinicalTrials.gov ID
- NCT07542600
- Acronym / sponsor ID
- INF_431/23
- Keywords
- Spa Treatment, Balneotherapy, Female Infertility, Hormonal Profile, IVF Preparation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Institute of Spa and Balneology, public research institutionUniversity, hospital or other
- Collaborators
- Františkovy lázně
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Spa Treatment (KLP) | Experimental | Procedure: Comrehensive 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female, age 20-40 years
- Diagnosis of infertility (primary or secondary)
- History of at least one unsuccessful embryo transfer
Key exclusion criteria (7 listed)
- Contraindications to spa treatment
- Acute gynecological inflammation
- Severe comorbidities affecting study outcomes
- Oncological disease
- Alcohol intake >20 g/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comrehensive Spa Treatment (KLP)A 21-day comprehensive spa treatment program including balneotherapy, peloid therapy, physiotherapy, and lifestyle interventions. | Procedure or surgery | Comprehensive Spa Treatment (KLP) |
Primary outcome
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.
4 secondary outcomes
Perceived stress (PSS-10)
Time frame: 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)
Pregnancy outcomes
Time frame: Assessed at 6 months and 12 months after completion of treatment
Body composition
Time frame: Baseline (Day 1) and end of treatment (Day 21)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comrehensive Spa Treatment (KLP) in people with Female Infertility and Reproductive Disorders, run by Institute of Spa and Balneology, public research institution at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hormonal profile (time frame: Baseline to end of treatment (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.