InfertilityNCT04971824
Physiotherapy in Assisted Reproductive Treatment
A study testing Physiotherapeutic intervention in people with Infertility, run by Klaudia Fabičovic, PT at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Physiotherapeutic intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Nov 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- acute or chronic serious disease
- taking oral contraceptive pills for the last six months
Trial locations and contacts
1 site in 1 country.
Czechia1 site
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
About this study
Official title: The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Physiotherapeutic intervention
- Keywords
- physiotherapy, assisted reproductive technologies, conception
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapeutic interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Physiotherapeutic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The total duration for each participant is three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start20 Nov 2020
- Primary completion20 Apr 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaudia Fabičovic, PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klaudia Fabičovic, PT, Charles University, Czech Republic
- Investigators
- Klaudia Fabičovic, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971824
- Sponsor's protocol ID
- GA UK 184121
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Some specific individual participant data will be shared (demographic data, the number of women who conceived in the end of study)
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies
- ClinicalTrials.gov ID
- NCT04971824
- Acronym / sponsor ID
- GA UK 184121
- Conditions
- Infertility
- Keywords
- physiotherapy, assisted reproductive technologies, conception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Klaudia Fabičovic, PTUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapeutic arm | Experimental | Procedure: Physiotherapeutic interventionThere 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- acute or chronic serious disease
- taking oral contraceptive pills for the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapeutic interventionThe 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. | Procedure or surgery | Physiotherapeutic arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. Some specific individual participant data will be shared (demographic data, the number of women who conceived in the end of study)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaudia Fabičovic principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapeutic intervention in people with Infertility, run by Klaudia Fabičovic, PT at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of combination treatment of physiotherapy and assisted reproductive technologies (time frame: The total duration for each participant is three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.