NCT04971824

Brief Summary

Research examines the effect of physiotherapy on treatment success by assisted reproductive technologies. It is based on a treatment of infertility by physiotherapeutic intervention after which the participants will undergo a treatment of assisted reproductive technologies (in vitro fertilisation). The work hypothesis is that physiotherapeutic treatment of female infertility improves the chances of conception by assisted reproductive technologies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

July 7, 2021

Last Update Submit

April 4, 2025

Conditions

Keywords

physiotherapyassisted reproductive technologiesconception

Outcome Measures

Primary Outcomes (1)

  • The effect of combination treatment of physiotherapy and assisted reproductive technologies

    The number of woman who conceived after treatment consisted of physiotherapy and follow- up treatment by assisted reproductive technologies compared to the number of women who underwent treatment by assisted reproductive technologies without physiotherapy

    The total duration for each participant is three months.

Study Arms (1)

Physiotherapeutic arm

EXPERIMENTAL

There will be the physiotherapeutic intervention, total duration for each participant is three months. The participants will be asked to fill three validated questionnaires in the beginning and in the end of study and keep records of their exercises, period and ovulation in their diaries.

Procedure: Physiotherapeutic intervention

Interventions

The physiotherapy consists in performing visceral manipulation of the pelvic and abdomen organs as well as doing special exercises (volunteers get a handout with instructions on how to exercise). The exercises include ones from the Mojzis´s method, Dynamic neuromuscular stabilisation, yoga or other therapeutic methods used by physiotherapists.

Physiotherapeutic arm

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe eligibility is based on gender because the study examines the effect of physiotherapy on woman who undergo treatment by assisted reproductive technologies.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • nullipara
  • age (18-39 years)
  • in the past at minimum one failed attempt of conception by assisted reproductive technologies
  • duration of infertility at minimum one year,
  • Body Mass Index (BMI) 18,5-34,9 according to the World Health Organization

You may not qualify if:

  • acute or chronic serious disease
  • taking oral contraceptive pills for the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Faculty of Medicine, Charles University, General University Hospital in Prague, Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech republic

Prague, 128 08, Czechia

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Klaudia Fabičovic

    First Faculty of Medicine, Charles University, General University Hospital in Prague, Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Physiotherapy

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 22, 2021

Study Start

November 20, 2020

Primary Completion

April 20, 2022

Study Completion

December 31, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Some specific individual participant data will be shared (demographic data, the number of women who conceived in the end of study)

Shared Documents
CSR

Locations