The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies
Primary Purpose
Infertility
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Physiotherapeutic intervention
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring physiotherapy, assisted reproductive technologies, conception
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
Sites / Locations
- 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 republicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiotherapeutic arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04971824
Brief Title
The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies
Official Title
Cooperation of Physiotherapy and Gynaecology in the Treatment of Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klaudia Michalcinova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
physiotherapy, assisted reproductive technologies, conception
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapeutic arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapeutic intervention
Intervention Description
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 Outcome Measure Information:
Title
The effect of combination treatment of physiotherapy and assisted reproductive technologies
Description
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
Time Frame
The total duration for each participant is three months.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The eligibility is based on gender because the study examines the effect of physiotherapy on woman who undergo treatment by assisted reproductive technologies.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaudia Michalčinová, Mgr.
Phone
+420 224 96 8598
Email
klaudia.michalcinova@vfn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaudia Michalčinová
Organizational 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaudia Michalčinová, Mgr.
Phone
+420 224 96 8598
Email
klaudia.michalcinova@vfn.cz
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Some specific individual participant data will be shared (demographic data, the number of women who conceived in the end of study)
Learn more about this trial
The Effect of Physiotherapy on Treatment Success by Assisted Reproductive Technologies
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