The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies

Cooperation of Physiotherapy and Gynaecology in the Treatment of Infertility

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Procedure: Physiotherapeutic intervention

Detailed Description

This is an intervention study which also shows how physiotherapists can improve cooperation between two professionals (gynaecologists and physiotherapists). The study is based on physiotherapeutic intervention which consist of three months of physiotherapy.

The physical therapy program consists of 10 individual therapeutic sessions. Every session lasts 45 minutes, frequency of the first six sessions is once a week, frequency of the last four sessions is once every two weeks. The duration for each participant is three months.

The participants will be examined by the physiotherapist during first and last therapy session and they will be asked to fill questionnaires and to keep records of their exercises, period and ovulation in their diaries. There will be three validated questionnaires:

The 36-Item Short Form Health Survey, which measures a health-related quality of life, also the State-Trait Anxiety Inventory which measures state and trait anxiety and the last one is the Female Sexual Function Index which measures sexual function in women. The participants will be asked to do physiotherapeutic exercises as self-treatment every day according to a handout they get at the first therapy session.

The results from intervention group will be compared to control group in which we use retrospective data (from year 2019) from Centre of Assisted Reproduction of General University Hospital in Prague. We will compare the number of women treated by assisted reproductive technologies but without physiotherapeutic intervention.

To sum up, in this study we compare the number of women who conceived following the assisted reproductive technologies with and without physiotherapeutic intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaudia Michalčinová, Mgr.; Phone Number: +420 224 96 8598; Email: klaudia.michalcinova@vfn.cz

Study Locations

• Czechia
  • Prague, Czechia, 128 08
    • Recruiting
    • 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
    • Contact: Klaudia Michalčinová, Mgr.; Phone Number: +420 224 96 8598; Email: klaudia.michalcinova@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapeutic arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Klaudia Michalcinova
• Investigators: Principal Investigator: Klaudia Michalčinová, 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

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: physiotherapy; assisted reproductive technologies; conception
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: GA UK 184121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Some specific individual participant data will be shared (demographic data, the number of women who conceived in the end of study)
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No