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NCT Number: NCT04971824

Physiotherapy in Assisted Reproductive Treatment

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.

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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapeutic intervention

Procedure

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.

Primary outcomes

  1. The effect of combination treatment of physiotherapy and assisted reproductive technologies

    Time frame: The total duration for each participant is three months.

    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

Sponsors and collaborators

Lead sponsor

Klaudia Fabičovic, PT

Other

Registry information

Official study title

The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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