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Clinical Trials/NCT04971824
NCT04971824CompletedNot Applicable

The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies

Klaudia Fabičovic, PT2 sites in 1 country42 target enrollmentStarted: November 20, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
42
Locations
2
Primary Endpoint
The effect of combination treatment of physiotherapy and assisted reproductive technologies

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 39 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Klaudia Fabičovic, PT
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Klaudia Fabičovic, PT

Master of Physiotherapy

Charles University, Czech Republic

Study Sites (2)

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