Infertility, FemaleNCT06105593
Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility: a Retrospective Study
An observational study of Infertility, Female, run by Harkány Thermal Rehabilitation Centre at 1 site in Hungary.
Trial summary
The goal of this observational study is to assess the effect of complex balneotherapy and physiotherapy treatment among infertile women treated in the Harkany Thermal Rehabilitation Center between July 01, 2007 and December 31, 2021. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Infertility, Female
- How many people
- 577 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: In the period between July 1, 2007 and December 31, 2021, received a 3-week complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center in inpatient care
Who may be able to join
- Female gender
- Diagnosed primary or secondary infertility
Who cannot join
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility at Harkany Thermal Rehabilitation Centre: a Retrospective Study
The goal of this observational study is to assess the effect of complex balneotherapy and physiotherapy treatment among infertile women treated in the Harkany Thermal Rehabilitation Center between July 01, 2007 and December 31, 2021. The main questions it aims to answer are:
- To what extent can the complex balneotherapy and physiotherapy treatment be an effective additional therapy in female infertility?
- What are the clinical changes behind infertility that can be helped by the complex balneotherapy and physiotherapy treatment? Participants will be asked to answer a questionnaire that we have prepared.
- Conditions
- Infertility, Female
- Keywords
- Balneotherapy, Physiotherapy, Questionnaire, Infertility
- Medical subject headings
- Infertility, Female, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
successful conception
Assessing with questionnaire. The participants are asked to answer the question whether they had a positive pregnancy test within 1 year after the complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center.
Measured: 12 months
Secondary outcomes (2)
successful delivery
Assessing with questionnaire. We ask the participants, if they managed to get pregnant within 1 year after the complex balneo and physiotherapy treatment to answer the question about what the outcome of their pregnancy was (for example: childbirth, miscarriage, stillbirth, etc.).
Measured: 12 months
the effect of the treatments on successful conception in different causes of infertility
Assessing with questionnaire and statistical analysis. Based on the answers to the questionnaire, we will use statistical analysis to investigate the proportion of successful pregnancies after the complex balneotherapy and physiotherapy treatment in the case of the different pathologies underlying infertility.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2023
- Primary completion5 Feb 2024
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harkány Thermal Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eszter Ambrus, Principal investigator, Harkany Thermal Rehabilitation CenterNóra Nusser, Study director, Harkany Thermal Rehabilitacion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105593
- Sponsor's protocol ID
- 9665-PTE 2023.
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility at Harkany Thermal Rehabilitation Centre: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06105593
- Acronym / sponsor ID
- 9665-PTE 2023.
- Conditions
- Infertility, Female
- Keywords
- Balneotherapy, Physiotherapy, Questionnaire, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Harkány Thermal Rehabilitation CentreUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 27 Oct 2023 (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.
The goal of this observational study is to assess the effect of complex balneotherapy and physiotherapy treatment among infertile women treated in the Harkany Thermal Rehabilitation Center between July 01, 2007 and December 31, 2021. The main questions it aims to answer are:
- To what extent can the complex balneotherapy and physiotherapy treatment be an effective additional therapy in female infertility?
- What are the clinical changes behind infertility that can be helped by the complex balneotherapy and physiotherapy treatment? Participants will be asked to answer a questionnaire that we have prepared.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In the period between July 1, 2007 and December 31, 2021, received a 3-week complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center in inpatient care
Key inclusion criteria (2 listed)
- Female gender
- Diagnosed primary or secondary infertility
Key exclusion criteria (1 listed)
- Lack of cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
successful conception
Time frame: 12 months
Assessing with questionnaire. The participants are asked to answer the question whether they had a positive pregnancy test within 1 year after the complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center.
2 secondary outcomes
successful delivery
Time frame: 12 months
the effect of the treatments on successful conception in different causes of infertility
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eszter Ambrus principal investigator
Harkany Thermal Rehabilitation Center
Nóra Nusser study director
Harkany Thermal Rehabilitacion Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Harkány Thermal Rehabilitation Centre at 1 site in Hungary.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful conception (time frame: 12 months). 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 13 Mar 2024.