Clinical trial NCT04971824: Physiotherapy in Assisted Reproductive Treatment
Official title: The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: physiotherapy
assisted reproductive technologies
conception
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of combination treatment of physiotherapy and assisted reproductive technologies
timeFrame: The total duration for each participant is three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: 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 officials:
affiliation: 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
name: Klaudia Fabičovic
role: PRINCIPAL_INVESTIGATOR
References: