Fertility IssuesNCT06690554
Health Promotion Model, Fertility Awareness, Preconception Knowledge and Attitude
A study testing Education Group in people with Fertility Issues and Preconception Injuries, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The effect of education given to preconceptional women in line with the health promotion model on fertility awareness, preconceptional knowledge and attitude levels Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues, Preconception Injuries, Health Behavior
- What is being tested?
- Education Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 1 Mar 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 18-35,
- Planning to get pregnant within a year,
- Literate,
- Can understand and speak Turkish,
- Agree to participate in the research.
Who cannot join
- Women who are pregnant,
- Women who are breastfeeding,
- Women who have been diagnosed with infertility,
- Women who have a history of chronic disease (hypertension, diabetes mellitus, hypothyroidism, etc.),
- Women who have a sexually transmitted disease (HIV, HPV, etc.),
- Women who have a physical disability,
- Women who have a psychiatric disease,
- Women who have a history of gynecological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Preconception Women in Line With the Health Promotion Model on Fertility Awareness, Preconception Knowledge and Attitude Levels
The effect of education given to preconceptional women in line with the health promotion model on fertility awareness, preconceptional knowledge and attitude levels
Read the detailed description
The research is a randomized controlled trial. The research will conducted with 206 women (intervention group n=103, control group n=103). It will consist of women between the ages of 18-35 who applied to the community health unit of Güneysınır District Health Directorate between Nov. 15, 2024-Mach 1, 2025.
Women who accept the research and are assigned to the intervention group will be given a five-day training to increase fertility awareness and preconceptional knowledge levels in line with the health promotion model. At the end of the fifth day, the Fertility Awareness Scale, Preconceptional Knowledge and Attitude Scale, and the Clinical Evaluation Form of the Health Promotion Plan for the Health Promotion Model will be applied to women who complete the training with a face-to-face interview technique. The women in the intervention group will be reached by phone at the end of the first and second months to remind them of their health promotion behaviors and to answer their questions and carry out follow-ups. At the end of the third month, women who have completed the training will be invited to the institution and the forms will be filled out again.
- Conditions
- Fertility Issues, Preconception Injuries, Health Behavior
- Being tested
- Education Group
- Keywords
- Fertility Awareness, Preconceptional Knowledge and Attitude, Health Promotion Model
- Medical subject headings
- Infertility, Preconception Injuries, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education GroupOther
Women will be given a five-day training in line with the health promotion model.
Information will be provided to women who apply to the hospital. Written consent documents will be obtained from women who agree to participate in the study.
Women assigned to the intervention group will attend classes in groups of 8-10. Women will be given a 60-minute training once a day for five days. The total training duration is five hours. Scales will be applied to women who complete the training at the end of the fifth day.
Women who have completed the training will be contacted by phone at the end of the first and second months, reminded of health promotion behaviors and their questions will be answered and follow-ups will be carried out.
At the end of the third month, women who have received training will be invited to the institution and the Fertility Awareness, Preconceptional Knowledge and Attitude will be filled out face-to-face for the final test.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | No intervention | * Information about the research will be provided. * Written consent will be obtained. * Personal Information Form, Fertility Awareness, Preconceptional Knowledge and Attitude will be applied to women who accept to participate in the research. * Five days after the first interview, women will be reached and the scales will be applied. * Three months after the first interview, women will be reached, invited to the institution and the scales will be applied again. |
| Education Group | Experimental | Women will be given a five-day training in line with the health promotion model.
* Information will be provided to women who apply to the hospital.
* Written consent documents will be obtained from women who agree to participate in the study.
* Women assigned to the intervention group will attend classes in groups of 8-10.
* Women will be given a 60-minute training once a day for five days.
* The total training duration is five hours.
* Scales will be applied to women who complete the training at the end of the fifth day.
* Women who have completed the training will be contacted by phone at the end of the first and second months, reminded of health promotion behaviors and their questions will be answered and follow-ups will be carried out.
* At the end of the third month, women who have received training will be invited to the institution and the Fertility Awareness, Preconceptional Knowledge and Attitude will be filled out face-to-face for the final test. Receives: Other: Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sociodemographic of women
Sociodemographic of women will be collected through surveys and compared and reported
Measured: 4 months
Comparison of obstetric features of women
Obstetric features of women will be collected through surveys and compared and reported
Measured: 4 months
Comparison of women's fertility awareness scale average scores by groups
The fertility awareness scale will be applied to women. The fertility awareness scale is 19-95 points (min-max), and as the score increases, fertility awareness scale increases.
Measured: 4 months
Comparison of women's preconceptional knowledge and attitude scale average scores by groups
Preconceptional knowledge and attitude scale will be applied to women. The preconceptional knowledge and attitude scaleis 43-215 points (min-max), and as the score increases, preconceptional knowledge and attitude increases.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start15 Nov 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
- Investigators
- Seyhan Çankaya, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690554
- Sponsor's protocol ID
- 2023/1011
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2024
- Last updated
- 28 Jul 2026
- Results posted
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Preconception Women in Line With the Health Promotion Model on Fertility Awareness, Preconception Knowledge and Attitude Levels
- ClinicalTrials.gov ID
- NCT06690554
- Acronym / sponsor ID
- 2023/1011
- Conditions
- Fertility Issues, Preconception Injuries, Health Behavior
- Keywords
- Fertility Awareness, Preconceptional Knowledge and Attitude, Health Promotion Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 15 Nov 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 effect of education given to preconceptional women in line with the health promotion model on fertility awareness, preconceptional knowledge and attitude levels
Detailed description
The research is a randomized controlled trial. The research will conducted with 206 women (intervention group n=103, control group n=103). It will consist of women between the ages of 18-35 who applied to the community health unit of Güneysınır District Health Directorate between Nov. 15, 2024-Mach 1, 2025.
Women who accept the research and are assigned to the intervention group will be given a five-day training to increase fertility awareness and preconceptional knowledge levels in line with the health promotion model. At the end of the fifth day, the Fertility Awareness Scale, Preconceptional Knowledge and Attitude Scale, and the Clinical Evaluation Form of the Health Promotion Plan for the Health Promotion Model will be applied to women who complete the training with a face-to-face interview technique. The women in the intervention group will be reached by phone at the end of the first and second months to remind them of their health promotion behaviors and to answer their questions and carry out follow-ups. At the end of the third month, women who have completed the training will be invited to the institution and the forms will be filled out again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | No intervention | –* Information about the research will be provided. * Written consent will be obtained. * Personal Information Form, Fertility Awareness, Preconceptional Knowledge and Attitude will be applied to women who accept to participate in the research. * Five days after the first interview, women will be reached and the scales will be applied. * Three months after the first interview, women will be reached, invited to the institution and the scales will be applied again. |
| Education Group | Experimental | Other: Education GroupWomen will be given a five-day training in line with the health promotion model. * Information will be provided to women who apply to the hospital. * Written consent documents will be obtained from women who agree to participate in the study. * Women assigned to the intervention group will attend classes in groups of 8-10. * Women will be given a 60-minute training once a day for five days. * The total training duration is five hours. * Scales will be applied to women who complete the training at the end of the fifth day. * Women who have completed the training will be contacted by phone at the end of the first and second months, reminded of health promotion behaviors and their questions will be answered and follow-ups will be carried out. * At the end of the third month, women who have received training will be invited to the institution and the Fertility Awareness, Preconceptional Knowledge and Attitude will be filled out face-to-face for the final test. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 18-35,
- Planning to get pregnant within a year,
- Literate,
- Can understand and speak Turkish,
- Agree to participate in the research.
Key exclusion criteria (8 listed)
- Women who are pregnant,
- Women who are breastfeeding,
- Women who have been diagnosed with infertility,
- Women who have a history of chronic disease (hypertension, diabetes mellitus, hypothyroidism, etc.),
- Women who have a sexually transmitted disease (HIV, HPV, etc.),
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 |
|---|---|---|
| Education GroupWomen will be given a five-day training in line with the health promotion model. Information will be provided to women who apply to the hospital. Written consent documents will be obtained from women who agree to participate in the study. Women assigned to the intervention group will attend classes in groups of 8-10. Women will be given a 60-minute training once a day for five days. The total training duration is five hours. Scales will be applied to women who complete the training at the end of the fifth day. Women who have completed the training will be contacted by phone at the end of the first and second months, reminded of health promotion behaviors and their questions will be answered and follow-ups will be carried out. At the end of the third month, women who have received training will be invited to the institution and the Fertility Awareness, Preconceptional Knowledge and Attitude will be filled out face-to-face for the final test. | Other | Education Group |
Primary outcome
Comparison of sociodemographic of women
Time frame: 4 months
Sociodemographic of women will be collected through surveys and compared and reported
Comparison of obstetric features of women
Time frame: 4 months
Obstetric features of women will be collected through surveys and compared and reported
Comparison of women's fertility awareness scale average scores by groups
Time frame: 4 months
The fertility awareness scale will be applied to women. The fertility awareness scale is 19-95 points (min-max), and as the score increases, fertility awareness scale increases.
Comparison of women's preconceptional knowledge and attitude scale average scores by groups
Time frame: 4 months
Preconceptional knowledge and attitude scale will be applied to women. The preconceptional knowledge and attitude scaleis 43-215 points (min-max), and as the score increases, preconceptional knowledge and attitude increases.
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 28 Jul 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.
Seyhan Çankaya principal investigator
Selcuk 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 Education Group in people with Fertility Issues and Preconception Injuries, run by Selcuk 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 5 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 28 Jul 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?
Comparison of sociodemographic of women (time frame: 4 months). The study lists 4 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 28 Jul 2026.