Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility: a Retrospective Study

Sponsor

Harkány Thermal Rehabilitation Centre (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06105593

Collaborator

(none)

878

Enrollment

Location

Anticipated Duration (Months)

174.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female

Study Design

Study Type:

Observational

Anticipated Enrollment :

878 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Combined Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility at Harkany Thermal Rehabilitation Centre: a Retrospective Study

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Outcome Measures

Primary Outcome Measures

successful conception [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.

Secondary Outcome Measures

successful delivery [12 months]
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.).
the effect of the treatments on successful conception in different causes of infertility [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female gender
Diagnosed primary or secondary infertility

Exclusion Criteria:

Lack of cooperation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harkany Thermal Rehabilitation Center	Harkány		Hungary	7815

Sponsors and Collaborators

Harkány Thermal Rehabilitation Centre

Investigators

Principal Investigator: Eszter Ambrus, Harkany Thermal Rehabilitation Center
Study Director: Nóra Nusser, Harkany Thermal Rehabilitacion Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Harkány Thermal Rehabilitation Centre

ClinicalTrials.gov Identifier:

NCT06105593

Other Study ID Numbers:

9665-PTE 2023.

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Harkány Thermal Rehabilitation Centre

Balneotherapy, Physiotherapy, Questionnaire, Infertility

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Oct 27, 2023