InfertilityNCT06317571
Evaluation of The Effect of Fertility Support Education Given to Infertile Couples
A study testing fertility support education in people with Infertility, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility
- What is being tested?
- fertility support education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 10 Aug 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with primary infertility
- have not received fertility support training before
- can speak Turkish
Who cannot join
- with psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi
Manisa, 45060
About this study
The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment.
Read the detailed description
Before the treatment, couples were given fertility support training for four weeks. After the treatment was completed, the couples' stress level and quality of life, women's self-efficacy, fertility readiness, cortisol levels and pregnancy outcomes were examined.
- Conditions
- Infertility
- Being tested
- fertility support education
- Keywords
- stress, cortisol Level, pregnancy Outcome, infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fertility support educationBehavioural
In the first module, female reproductive organs, the occurrence of pregnancy and the effect of stress on fertility are explained to women using models and training booklets. The effects of affirmation, which is one of the ways to positively affect the consciousness, and imagination, visualization and relaxation techniques, which are ways to positively affect the subconscious, on body and reproductive functions are explained. In the second module, women and their partners were also trained, and the effect of lifestyle on reproductive health was explained through the second module training booklet. In the third module, an example of a one-week program in which they could apply the methods described in the training before starting their treatments was introduced. In the fourth module, treatment process was explained to women and the practices described in the training were shared, which they could do to relax during this process.
| Study group | Role | What they receive |
|---|---|---|
| fertility support training | Experimental | The group will receive fertility support training. Receives: Behavioral: fertility support education |
| routine care | No intervention | They will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infertility Stress Scale
This scale, which can be applied to both men and women, consists of three subscales and 14 items. The sub-dimensions of the scale are personal space, marital space and social space. A high score from the subscales of the scale indicates that stress has increased, while a low score indicates that stress has decreased.
Measured: two month
Infertility Self-Efficacy Scale-Short Form
The scale was developed to evaluate the self-efficacy perceptions of infertile individuals about their cognitive, emotional and behavioral skill strengths. A 10-item short form of this scale, which consists of 16 items, was created in 2006. A minimum of 8 and a maximum of 32 points are obtained from the scale, and the higher the score obtained from the scale, the higher the perception of self-efficacy is considered.
Measured: two month
Fertility Readiness Scale
The scale consists of three sub-dimensions: "Hope and Awareness", "Positive Emotions and Thoughts", and "Ready Body and Brain". Getting a high score on this scale indicates strong fertility readiness. The minimum score from the scale is 23 points and the maximum score is 115 points. The median score of this scale is 56 and it is stated that this score can be taken as the cut-off value. A score of 56 points or higher from the scale indicates that the woman feels more ready for pregnancy.
Measured: two month
Fertiqol Quality of Life Scale
The scale evaluates quality of life. The core module consists of four dimensions: emotional, mind-body, relational and social, and the treatment module consists of two sub-dimensions: treatment environment and treatment tolerance. The total score of the scale varies between 0-100, and an increase in the total score indicates an increase in the quality of life.
Measured: two month
Blood cortisol level
An increase in blood cortisol level indicates that stress increases, and a decrease indicates that stress decreases.
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start15 Mar 2021
- Primary completion28 Dec 2021
- Study completion10 Aug 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with intervention group and control group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Özge TOPSAKAL, PhD, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317571
- Sponsor's protocol ID
- CelalBayarU-SBF-OT-01
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Fertility Support Education Given to Infertile Couples
- ClinicalTrials.gov ID
- NCT06317571
- Acronym / sponsor ID
- CelalBayarU-SBF-OT-01
- Conditions
- Infertility
- Keywords
- stress, cortisol Level, pregnancy Outcome, infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 19 Mar 2024 (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.
The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment.
Detailed description
Before the treatment, couples were given fertility support training for four weeks. After the treatment was completed, the couples' stress level and quality of life, women's self-efficacy, fertility readiness, cortisol levels and pregnancy outcomes were examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| fertility support training | Experimental | Behavioral: fertility support educationThe group will receive fertility support training. |
| routine care | No intervention | –They will receive routine care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosed with primary infertility
- have not received fertility support training before
- can speak Turkish
Key exclusion criteria (1 listed)
- with psychiatric illness
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 |
|---|---|---|
| fertility support educationIn the first module, female reproductive organs, the occurrence of pregnancy and the effect of stress on fertility are explained to women using models and training booklets. The effects of affirmation, which is one of the ways to positively affect the consciousness, and imagination, visualization and relaxation techniques, which are ways to positively affect the subconscious, on body and reproductive functions are explained. In the second module, women and their partners were also trained, and the effect of lifestyle on reproductive health was explained through the second module training booklet. In the third module, an example of a one-week program in which they could apply the methods described in the training before starting their treatments was introduced. In the fourth module, treatment process was explained to women and the practices described in the training were shared, which they could do to relax during this process. | Behavioural | fertility support training |
Primary outcome
Infertility Stress Scale
Time frame: two month
This scale, which can be applied to both men and women, consists of three subscales and 14 items. The sub-dimensions of the scale are personal space, marital space and social space. A high score from the subscales of the scale indicates that stress has increased, while a low score indicates that stress has decreased.
Infertility Self-Efficacy Scale-Short Form
Time frame: two month
The scale was developed to evaluate the self-efficacy perceptions of infertile individuals about their cognitive, emotional and behavioral skill strengths. A 10-item short form of this scale, which consists of 16 items, was created in 2006. A minimum of 8 and a maximum of 32 points are obtained from the scale, and the higher the score obtained from the scale, the higher the perception of self-efficacy is considered.
Fertility Readiness Scale
Time frame: two month
The scale consists of three sub-dimensions: "Hope and Awareness", "Positive Emotions and Thoughts", and "Ready Body and Brain". Getting a high score on this scale indicates strong fertility readiness. The minimum score from the scale is 23 points and the maximum score is 115 points. The median score of this scale is 56 and it is stated that this score can be taken as the cut-off value. A score of 56 points or higher from the scale indicates that the woman feels more ready for pregnancy.
Fertiqol Quality of Life Scale
Time frame: two month
The scale evaluates quality of life. The core module consists of four dimensions: emotional, mind-body, relational and social, and the treatment module consists of two sub-dimensions: treatment environment and treatment tolerance. The total score of the scale varies between 0-100, and an increase in the total score indicates an increase in the quality of life.
Blood cortisol level
Time frame: two month
An increase in blood cortisol level indicates that stress increases, and a decrease indicates that stress decreases.
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 20 Mar 2024.
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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.
Özge TOPSAKAL, PhD principal investigator
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fertility support education in people with Infertility, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 20 Mar 2024. 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 Turkey (Türkiye). 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?
Infertility Stress Scale (time frame: two month). The study lists 5 primary outcomes in all. 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 20 Mar 2024.