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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06105593
Other study ID # 9665-PTE 2023.
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date May 2024

Study information

Verified date March 2024
Source Harkány Thermal Rehabilitation Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 577
Est. completion date May 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Female gender - Diagnosed primary or secondary infertility Exclusion Criteria: - Lack of cooperation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hungary Harkany Thermal Rehabilitation Center Harkány

Sponsors (1)

Lead Sponsor Collaborator
Harkány Thermal Rehabilitation Centre

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary 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.). 12 months
Secondary 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. 12 months
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