NCT06105593

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
577

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

October 17, 2023

Last Update Submit

March 12, 2024

Conditions

Infertility, Female

Keywords

Balneotherapy, Physiotherapy, Questionnaire, Infertility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • successful delivery

    12 months

  • the effect of the treatments on successful conception in different causes of infertility

    12 months

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Female gender
  • Diagnosed primary or secondary infertility

You may not qualify if:

  • Lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harkany Thermal Rehabilitation Center

Harkány, 7815, Hungary

Location

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Eszter Ambrus

    Harkany Thermal Rehabilitation Center

    PRINCIPAL INVESTIGATOR

  • Nóra Nusser

    Harkany Thermal Rehabilitacion Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 27, 2023

Study Start

September 1, 2023

Primary Completion

February 5, 2024

Study Completion

May 1, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)