Fertility DisordersNCT06799507
The Effect of Mindfulness-Based Lifestyle Support Program on Infertile Women
A study testing Interventions Based on Mindfulness and Routine clinical procedure in people with Fertility Disorders and Infertility (IVF Patients), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to determine whether a mindfulness-based lifestyle support program would improve quality of life, lifestyle, mindfulness, attention and meditation level and treatment outcomes in women undergoing IVF treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertility Disorders, Infertility (IVF Patients)
- What is being tested?
- Interventions Based on Mindfulness and Routine clinical procedure
- 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
- 31 Jan 2025to 5 Oct 2026
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary infertility,
- Going to undergo IVF treatment,
- Under 45 years of age,
- Having a smart phone or computer
Who cannot join
- Participate in any program related to mindfulness
- Prior mindfulness training
- Knowing/doing mindfulness practices beforehand
- Having any psychiatric disorder
- Having any chronic disease
- Disability (hearing/vision etc.)
- Attending less than 80% of the trainings (missing more than 2 Mindfulness trainings)
- Conception during research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Lifestyle Support Program on Quality of Life, Lifestyle, Mindfulness Level and Treatment Outcomes in Infertile Women
This randomized controlled trial aimed to determine whether a mindfulness-based lifestyle support program would improve quality of life, lifestyle, mindfulness, attention and meditation level and treatment outcomes in women undergoing IVF treatment.
Read the detailed description
Having a diagnosis of infertility is often perceived by individuals as a physically and psychologically challenging experience. At every step of infertility treatment, women face different levels of anxiety and stress. In this direction, recent studies have emphasized the importance of acquiring fertility-supportive lifestyle behaviors, especially to eliminate infertility risk factors. It is stated that positive changes in lifestyle behaviors can positively affect treatment outcomes and quality of life. Recently, awareness-based interventions to support psychological well-being and healthy life behaviors in couples undergoing fertility treatment have gained importance in the literature. There are many psychosocial variables that can affect individuals' perception of quality of life in coping strategies of psychological interventions such as mindfulness. The reason for this is the acquisition of coping skills with more use of mindfulness skills. With the mindfulness approach, infertile women are encouraged to be open to encountering painful situations in the treatment process at any time, not to approach their pain judgmentally, and to see their experiences in the treatment process as a part of humanity. As a result, quality of life can improve by being aware of their body, emotions and thoughts.
The quality of life and lifestyle habits of women receiving fertility support are generally not a factor that is highly evaluated by health professionals. Clinical practice focuses more on medical procedures. However, in addition to medical care, psychological interventions that can support success should also be included in this treatment. Providing healthy lifestyle changes that can reduce stress and increase fertility and support fertility is very useful and necessary for public health.
It is thought that the "Mindfulness-Based Lifestyle Support Program" developed by the researchers and prepared in accordance with adult education principles will be effective in regulating the psychological well-being, quality of life and lifestyle of women receiving in vitro fertilization treatment with fertility-supportive lifestyle trainings and mindfulness practices, and will be effective in achieving more successful treatment results by positively affecting reproductive organs and hormonal balance. In addition, in order to see the effects of this mindfulness-based program more quantitatively, it is planned to follow up the women with wearable technology that gives subjective feedback on brain activities, attention and meditation levels.
The aim of this study is to evaluate the quality of life, lifestyle, mindfulness, attention and meditation levels and treatment outcomes of women receiving in vitro fertilization treatment with fertility-supportive lifestyle education in the "Mindfulness-Based Lifestyle Support Program", which was developed by the researchers as a hybrid and prepared in accordance with adult education principles, in a randomized controlled trial.
The research will be conducted as "hybrid education" face-to-face and online via zoom platform with women who apply to a university hospital IVF Center in Izmir for in vitro fertilization treatment and meet the sampling criteria reached by the researcher. In the study, infertile women will be randomized and divided into 2 groups as intervention and control. The intervention group will receive Mindfulness-based lifestyle support program, while the control group will not be subjected to any training and will receive routine clinical care. The effects of the Mindfulness-based lifestyle support program on infertile women's quality of life, lifestyle, mindfulness level, and treatment outcomes will be evaluated with scales and prepared forms, and the level of attention and meditation will be evaluated with the NeuroSky Mindwave device.
- Conditions
- Fertility Disorders, Infertility (IVF Patients)
- Being tested
- Interventions Based on Mindfulness, Routine clinical procedure
- Keywords
- Infertility, Mindfulness, Quality of Life, Life Style
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions Based on MindfulnessBehavioural
Affirmation, Relaxation, Mindfulness, Meditation, Healthy Lifestyle, Quality Life
Routine clinical procedureOther
Routine clinical procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention: Intervention Based on Mindfulness Receives: Behavioral: Interventions Based on Mindfulness |
| Control | Active comparator | Control: Routine clinical procedure Receives: Other: Routine clinical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fertility Quality of Life
Fertility quality of life tool (FertiQoL): This scale is a self-rating questionnaire specifically designed to assess the quality of life of infertile patients. It has good reliability and efficacy in many countries. The Cronbach's α value of the Turkish version of FertiQoL is 0.905. The FertiQoL scale includes two modules: The Core FertiQoL module and the optional Treatment FertiQoL module. The Core FertiQoL module is divided into four domains: emotional (6 items), mind-body (6 items), relationship (6 items) and social (6 items). The optional Treatment FertiQoL module is divided into two domains: environment (6 items) and tolerability of infertility treatment (4 items). Each item has a score of 0-4 points and the total scale and subscale scores can be converted into 0-100 point scales. The higher the scores obtained from the scale, the higher the fertility-related quality of life.
Measured: through study completion, average 28 days
Fertility Healthy Lifestyle
Fertility Healthy Lifestyle Assessment Scale (FHLAS): This is a 46-item scale developed by Bilgiç et al. to assess healthy lifestyles that contribute to improving fertility in women and men. It consists of seven sub-dimensions and is a 5-point Likert-type scale (1-strongly disagree, 2- disagree, 3 undecided, 4- agree, and 5-strongly agree). The seven sub-dimensions of the scale are emotional well-being, physical activity, sleep, nutrition, technology, hygiene and spirituality. Cronbach's Alpha value of the scale was found to be 0.87. The lowest score obtained from the scale is 46 and the highest score is 230. High scores obtained from the total scale and its sub-dimensions indicate that individuals have a lifestyle associated with healthier fertility.
Measured: through study completion, average 28 days
Secondary outcomes (5)
Mindfulness
Mindful Attention Awareness Scale (MAAS): aims to determine the general tendency to be aware of and attentive to momentary experiences in daily life. The 6-point Likert-type scale consists of 15 items and one dimension. As a result of the reliability analysis, the Cronbach Alpha internal consistency coefficient of the scale was calculated as .80 and the test-retest correlation was calculated as .86. High scores on the scale indicate high levels of mindfulness.
Measured: through study completion, average 28 days
Attention and Meditation Level
NeuroSky Mindwave: The device will be implemented by the researcher. This wearable EEG device was developed as a direct biosensor to detect attention and meditation states by reading the electrical activity of the brain. The device features dry active technology, without the need for gel. The two metal parts of the ear clip are attached in contact with the earlobe and the sensor part is adjusted to contact the forehead above the left eye. With the help of the sensors, Attention and Meditation levels of the brain can be calculated. Measurement of the level of Mindfulness and Meditation will be obtained for both the intervention and the control group. In order to obtain a healthy signal with the device, there should be no elements such as hair, dead skin or makeup to prevent contact.
Measured: through study completion, average 28 days
Treatment Outcome-Number of Embryos
The number of embryos, which is one of the treatment outcomes of women who completed the Mindfulness-Based Lifestyle Support Program, will be recorded in the "Treatment Outcome Form" created by the researchers. The information in the relevant form will be recorded by the researcher after the oocyte retrieval process by interviewing the women and looking at the system records.
Measured: through study completion, average 28 day
Treatment Outcome-Pregnancy Rate
The pregnancy rate, which is one of the treatment outcomes of women who completed the Mindfulness-Based Lifestyle Support Program, will be recorded on the "Treatment Outcome Form" created by the researchers. The information in the relevant form will be recorded by the researcher by interviewing the women and checking the system records after the pregnancy test procedure performed approximately 10-12 days after the embryo transfer procedure.
Measured: after study completion, average 10-12 day
Education Program Satisfaction
The satisfaction of the women who completed the Mindfulness-Based Lifestyle Support Program will be evaluated by the researchers by asking the women about their satisfaction with this program. It will be evaluated with a visual satisfaction scale created by the researcher, which includes a rating from 0 to 10 (0-not satisfied at all, 10-very satisfied).
Measured: through study completion, average 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start31 Jan 2025
- Primary completion5 Oct 2026
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Yanık, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799507
- Sponsor's protocol ID
- DEU-HF-FY-01
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Lifestyle Support Program on Quality of Life, Lifestyle, Mindfulness Level and Treatment Outcomes in Infertile Women
- ClinicalTrials.gov ID
- NCT06799507
- Acronym / sponsor ID
- DEU-HF-FY-01
- Conditions
- Fertility Disorders, Infertility (IVF Patients)
- Keywords
- Infertility, Mindfulness, Quality of Life, Life Style
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 5 Oct 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 29 Jan 2025 (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.
This randomized controlled trial aimed to determine whether a mindfulness-based lifestyle support program would improve quality of life, lifestyle, mindfulness, attention and meditation level and treatment outcomes in women undergoing IVF treatment.
Detailed description
Having a diagnosis of infertility is often perceived by individuals as a physically and psychologically challenging experience. At every step of infertility treatment, women face different levels of anxiety and stress. In this direction, recent studies have emphasized the importance of acquiring fertility-supportive lifestyle behaviors, especially to eliminate infertility risk factors. It is stated that positive changes in lifestyle behaviors can positively affect treatment outcomes and quality of life. Recently, awareness-based interventions to support psychological well-being and healthy life behaviors in couples undergoing fertility treatment have gained importance in the literature. There are many psychosocial variables that can affect individuals' perception of quality of life in coping strategies of psychological interventions such as mindfulness. The reason for this is the acquisition of coping skills with more use of mindfulness skills. With the mindfulness approach, infertile women are encouraged to be open to encountering painful situations in the treatment process at any time, not to approach their pain judgmentally, and to see their experiences in the treatment process as a part of humanity. As a result, quality of life can improve by being aware of their body, emotions and thoughts.
The quality of life and lifestyle habits of women receiving fertility support are generally not a factor that is highly evaluated by health professionals. Clinical practice focuses more on medical procedures. However, in addition to medical care, psychological interventions that can support success should also be included in this treatment. Providing healthy lifestyle changes that can reduce stress and increase fertility and support fertility is very useful and necessary for public health.
It is thought that the "Mindfulness-Based Lifestyle Support Program" developed by the researchers and prepared in accordance with adult education principles will be effective in regulating the psychological well-being, quality of life and lifestyle of women receiving in vitro fertilization treatment with fertility-supportive lifestyle trainings and mindfulness practices, and will be effective in achieving more successful treatment results by positively affecting reproductive organs and hormonal balance. In addition, in order to see the effects of this mindfulness-based program more quantitatively, it is planned to follow up the women with wearable technology that gives subjective feedback on brain activities, attention and meditation levels.
The aim of this study is to evaluate the quality of life, lifestyle, mindfulness, attention and meditation levels and treatment outcomes of women receiving in vitro fertilization treatment with fertility-supportive lifestyle education in the "Mindfulness-Based Lifestyle Support Program", which was developed by the researchers as a hybrid and prepared in accordance with adult education principles, in a randomized controlled trial.
The research will be conducted as "hybrid education" face-to-face and online via zoom platform with women who apply to a university hospital IVF Center in Izmir for in vitro fertilization treatment and meet the sampling criteria reached by the researcher. In the study, infertile women will be randomized and divided into 2 groups as intervention and control. The intervention group will receive Mindfulness-based lifestyle support program, while the control group will not be subjected to any training and will receive routine clinical care. The effects of the Mindfulness-based lifestyle support program on infertile women's quality of life, lifestyle, mindfulness level, and treatment outcomes will be evaluated with scales and prepared forms, and the level of attention and meditation will be evaluated with the NeuroSky Mindwave device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Interventions Based on MindfulnessIntervention: Intervention Based on Mindfulness |
| Control | Active comparator | Other: Routine clinical procedureControl: Routine clinical procedure |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary infertility,
- Going to undergo IVF treatment,
- Under 45 years of age,
- Having a smart phone or computer
Key exclusion criteria (8 listed)
- Participate in any program related to mindfulness
- Prior mindfulness training
- Knowing/doing mindfulness practices beforehand
- Having any psychiatric disorder
- Having any chronic disease
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 |
|---|---|---|
| Interventions Based on MindfulnessAffirmation, Relaxation, Mindfulness, Meditation, Healthy Lifestyle, Quality Life | Behavioural | Intervention |
| Routine clinical procedureRoutine clinical procedure | Other | Control |
Primary outcome
The Fertility Quality of Life
Time frame: through study completion, average 28 days
Fertility quality of life tool (FertiQoL): This scale is a self-rating questionnaire specifically designed to assess the quality of life of infertile patients. It has good reliability and efficacy in many countries. The Cronbach's α value of the Turkish version of FertiQoL is 0.905. The FertiQoL scale includes two modules: The Core FertiQoL module and the optional Treatment FertiQoL module. The Core FertiQoL module is divided into four domains: emotional (6 items), mind-body (6 items), relationship (6 items) and social (6 items). The optional Treatment FertiQoL module is divided into two domains: environment (6 items) and tolerability of infertility treatment (4 items). Each item has a score of 0-4 points and the total scale and subscale scores can be converted into 0-100 point scales. The higher the scores obtained from the scale, the higher the fertility-related quality of life.
Fertility Healthy Lifestyle
Time frame: through study completion, average 28 days
Fertility Healthy Lifestyle Assessment Scale (FHLAS): This is a 46-item scale developed by Bilgiç et al. to assess healthy lifestyles that contribute to improving fertility in women and men. It consists of seven sub-dimensions and is a 5-point Likert-type scale (1-strongly disagree, 2- disagree, 3 undecided, 4- agree, and 5-strongly agree). The seven sub-dimensions of the scale are emotional well-being, physical activity, sleep, nutrition, technology, hygiene and spirituality. Cronbach's Alpha value of the scale was found to be 0.87. The lowest score obtained from the scale is 46 and the highest score is 230. High scores obtained from the total scale and its sub-dimensions indicate that individuals have a lifestyle associated with healthier fertility.
5 secondary outcomes
Mindfulness
Time frame: through study completion, average 28 days
Attention and Meditation Level
Time frame: through study completion, average 28 days
Treatment Outcome-Number of Embryos
Time frame: through study completion, average 28 day
Treatment Outcome-Pregnancy Rate
Time frame: after study completion, average 10-12 day
Education Program Satisfaction
Time frame: through study completion, average 28 days
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions Based on Mindfulness and Routine clinical procedure in people with Fertility Disorders and Infertility (IVF Patients), run by Dokuz Eylul 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 4 inclusion and 8 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 27 Oct 2026. 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?
The Fertility Quality of Life (time frame: through study completion, average 28 days). The study lists 2 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 27 Oct 2026.