InfertilityNCT07557069
Swanson-Based Supportive Care for Infertility Stress and Coping in Couples Undergoing ART
A study testing Swanson Caring Theory-based supportive care in people with Infertility, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if supportive care based on Swanson's Caring Theory can reduce stress and improve coping in couples undergoing infertility treatment with assisted reproductive treatment (ART), including in vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- Swanson Caring Theory-based supportive care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2022to 5 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Couples diagnosed with primary infertility
- Aged 18 years or older
- Able to read and understand Turkish
- No diagnosed psychiatric disorder
- No communication problems or mental disability
- Scheduled to undergo assisted reproductive treatment (ART)
- Participation as a couple (both partners enrolled together)
Who cannot join
- - No oocytes obtained during oocyte retrieval
- No sperm obtained from the male partner
- No embryo available for transfer
- Discontinuation of treatment during the study process
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Health Practice and Research Center
Samsun, 55200
About this study
Official title: A Swanson's Caring Theory-Informed Supportive Care Intervention for Reducing Infertility-related Stress and Improving Coping Strategies in Couples Undergoing Assisted Reproductive Treatment
The goal of this clinical trial is to learn if supportive care based on Swanson's Caring Theory can reduce stress and improve coping in couples undergoing infertility treatment with assisted reproductive treatment (ART), including in vitro fertilization (IVF).
Infertility can be emotionally challenging and may affect both partners. Many couples experience stress, uncertainty, and difficulty coping during treatment.
Read more
The main questions this study aims to answer are:
- Does this supportive care program reduce infertility-related stress in women and men?
- Does it improve how couples cope with the challenges of infertility treatment? Researchers will randomly assign (by chance) couples to one of two groups: a supportive care group or a routine care group.
All participants will continue their planned fertility treatment.
Participants will:
- Be randomly assigned to one of the two groups
- Receive either supportive care (education and counseling throughout treatment) or routine care
- Complete questionnaires about stress and coping before treatment, after the oocyte retrieval procedure, and one month after embryo transfer
- Couples who do not achieve pregnancy will complete one additional questionnaire Swanson's Caring Theory is a care approach that focuses on understanding individuals' experiences, providing emotional support, and helping people cope with difficult situations.
The results of this study may help improve structured supportive care for couples undergoing infertility treatment and promote more effective coping and lower stress during the treatment process.
Read the detailed description
Infertility is a significant life event that can affect individuals and couples at multiple levels, including emotional well-being, relationship dynamics, and future life planning. The World Health Organization defines infertility as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Infertility-related stress often increases throughout the diagnostic and treatment process, and individuals undergoing ART frequently report elevated stress levels and difficulties in coping. Although infertility is experienced by both partners, supportive care interventions have largely focused on individuals, and structured approaches that include both partners remain limited.
Healthcare professionals, including midwives and nurses, are well positioned to provide continuous support during infertility treatment. Structured supportive care interventions may help reduce infertility-related stress and enhance coping; however, theory-informed and couple-inclusive care models are still limited in infertility treatment settings. Therefore, this single-blind randomized controlled trial was designed to evaluate the effects of a supportive care program based on Swanson's Caring Theory on infertility-related stress and coping in couples undergoing ART.
Swanson's Caring Theory was originally developed in the context of pregnancy loss and focuses on how caring processes support individuals in coping with loss, uncertainty, and emotional distress. The theory has since been applied across various clinical settings requiring supportive care. Unsuccessful assisted reproductive treatment may be perceived as a significant loss and can evoke grief-like responses. Therefore, this framework provides a relevant approach for supporting individuals undergoing infertility treatment.
Couples were randomly assigned to either an intervention group receiving structured education and counseling throughout the treatment process or a control group receiving routine care.
The sample size was determined based on the primary outcome, assuming 95% confidence, 95% statistical power, and an effect size of 0.60, resulting in a required sample size of 42 participants per group. To account for potential attrition, additional participants were included, leading to a total sample of 100 individuals (50 couples).
Data were collected at three time points: before treatment initiation, after oocyte retrieval, and one month after embryo transfer. For participants who did not achieve pregnancy, an additional follow-up assessment was conducted. The primary outcomes of the study were infertility-related stress and coping strategies.
Statistical analyses were performed using SPSS software (version 28). Descriptive statistics, including means, standard deviations, frequencies, and percentages, were used to summarize participant characteristics and outcome variables. For women and men, between-group comparisons at each assessment point were conducted using independent-samples t tests, and within-group changes between the first and second assessments were examined using paired-samples t tests. For participants with unsuccessful ART outcomes, third-assessment scores were compared between the intervention and control groups using independent-samples t tests. Statistical significance was set at p < 0.05.
The findings are expected to contribute to the development of structured, theory-informed supportive care approaches for couples undergoing infertility treatment.
- Conditions
- Infertility
- Being tested
- Swanson Caring Theory-based supportive care
- Keywords
- Infertility, Assisted Reproductive Technology, In Vitro Fertilization, Infertility-related Stress, Coping, Supportive Care, Swanson Caring Theory, Couples, Randomized Controlled Trial
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swanson Caring Theory-based supportive careBehavioural
A structured supportive care program based on Swanson's Caring Theory, including seven sessions of education, counseling, and emotional support delivered by a midwife to infertile couples throughout the ART process. The program was integrated into key treatment stages (ovarian stimulation, oocyte retrieval, and embryo transfer) and included both face-to-face and online sessions, focusing on reducing infertility-related stress and strengthening coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Swanson-Based Supportive Care | Experimental | Participants receive structured supportive care based on Swanson's Caring Theory, including education and counseling throughout the ART process. Receives: Behavioral: Swanson Caring Theory-based supportive care |
| Routine Care | No intervention | Participants receive routine care provided by the IVF center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infertility-related stress
Infertility-related stress assessed using the COMPI Fertility Problem Stress Scales, a 14-item multidimensional scale measuring personal, marital, and social aspects of infertility-related stress. Total scores range from 0 to 50, with higher scores indicating higher levels of infertility-related stress.
Measured: Baseline, after oocyte retrieval, and 1 month after embryo transfer
Secondary outcomes (1)
Coping strategies
Coping strategies assessed using the COMPI Coping Strategy Scales, a 19-item scale evaluating strategies for managing infertility-related stress, including active, passive, and meaning-based coping. Total scores vary across subscales, with higher scores indicating greater use of coping strategies.
Measured: Baseline, after oocyte retrieval, and 1 month after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 Jul 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Model description
- Participants were randomly assigned in a parallel-group design to either an intervention group receiving structured supportive care based on Swanson's Caring Theory or a control group receiving routine care. Outcomes were measured at baseline, after oocyte retrieval, and one month after embryo transfer.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap TEMİZ, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557069
- Sponsor's protocol ID
- OMU-SWANSON CARE-IVF-2024
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data are not publicly available due to ethical and confidentiality considerations but may be shared upon reasonable request, subject to approval by the relevant ethics committee.
Publications
Arslan B, Temiz S. A Swanson's caring theory-based intervention to reduce infertility-related stress and improve coping strategies in women and their partners undergoing assisted reproductive treatment (ART): a randomized controlled trial. Arch Womens Ment Health. 2026 Aug 19;29(5):115. doi: 10.1007/s00737-026-01750-x.
PubMed 42613486
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Swanson's Caring Theory-Informed Supportive Care Intervention for Reducing Infertility-related Stress and Improving Coping Strategies in Couples Undergoing Assisted Reproductive Treatment
- ClinicalTrials.gov ID
- NCT07557069
- Acronym / sponsor ID
- OMU-SWANSON CARE-IVF-2024
- Conditions
- Infertility
- Keywords
- Infertility, Assisted Reproductive Technology, In Vitro Fertilization, Infertility-related Stress, Coping, Supportive Care, Swanson Caring Theory, Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 29 Apr 2026 (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 goal of this clinical trial is to learn if supportive care based on Swanson's Caring Theory can reduce stress and improve coping in couples undergoing infertility treatment with assisted reproductive treatment (ART), including in vitro fertilization (IVF).
Infertility can be emotionally challenging and may affect both partners. Many couples experience stress, uncertainty, and difficulty coping during treatment.
The main questions this study aims to answer are:
- Does this supportive care program reduce infertility-related stress in women and men?
- Does it improve how couples cope with the challenges of infertility treatment? Researchers will randomly assign (by chance) couples to one of two groups: a supportive care group or a routine care group.
All participants will continue their planned fertility treatment.
Participants will:
- Be randomly assigned to one of the two groups
- Receive either supportive care (education and counseling throughout treatment) or routine care
- Complete questionnaires about stress and coping before treatment, after the oocyte retrieval procedure, and one month after embryo transfer
- Couples who do not achieve pregnancy will complete one additional questionnaire Swanson's Caring Theory is a care approach that focuses on understanding individuals' experiences, providing emotional support, and helping people cope with difficult situations.
The results of this study may help improve structured supportive care for couples undergoing infertility treatment and promote more effective coping and lower stress during the treatment process.
Detailed description
Infertility is a significant life event that can affect individuals and couples at multiple levels, including emotional well-being, relationship dynamics, and future life planning. The World Health Organization defines infertility as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Infertility-related stress often increases throughout the diagnostic and treatment process, and individuals undergoing ART frequently report elevated stress levels and difficulties in coping. Although infertility is experienced by both partners, supportive care interventions have largely focused on individuals, and structured approaches that include both partners remain limited.
Healthcare professionals, including midwives and nurses, are well positioned to provide continuous support during infertility treatment. Structured supportive care interventions may help reduce infertility-related stress and enhance coping; however, theory-informed and couple-inclusive care models are still limited in infertility treatment settings. Therefore, this single-blind randomized controlled trial was designed to evaluate the effects of a supportive care program based on Swanson's Caring Theory on infertility-related stress and coping in couples undergoing ART.
Swanson's Caring Theory was originally developed in the context of pregnancy loss and focuses on how caring processes support individuals in coping with loss, uncertainty, and emotional distress. The theory has since been applied across various clinical settings requiring supportive care. Unsuccessful assisted reproductive treatment may be perceived as a significant loss and can evoke grief-like responses. Therefore, this framework provides a relevant approach for supporting individuals undergoing infertility treatment.
Couples were randomly assigned to either an intervention group receiving structured education and counseling throughout the treatment process or a control group receiving routine care.
The sample size was determined based on the primary outcome, assuming 95% confidence, 95% statistical power, and an effect size of 0.60, resulting in a required sample size of 42 participants per group. To account for potential attrition, additional participants were included, leading to a total sample of 100 individuals (50 couples).
Data were collected at three time points: before treatment initiation, after oocyte retrieval, and one month after embryo transfer. For participants who did not achieve pregnancy, an additional follow-up assessment was conducted. The primary outcomes of the study were infertility-related stress and coping strategies.
Statistical analyses were performed using SPSS software (version 28). Descriptive statistics, including means, standard deviations, frequencies, and percentages, were used to summarize participant characteristics and outcome variables. For women and men, between-group comparisons at each assessment point were conducted using independent-samples t tests, and within-group changes between the first and second assessments were examined using paired-samples t tests. For participants with unsuccessful ART outcomes, third-assessment scores were compared between the intervention and control groups using independent-samples t tests. Statistical significance was set at p < 0.05.
The findings are expected to contribute to the development of structured, theory-informed supportive care approaches for couples undergoing infertility treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a parallel-group design to either an intervention group receiving structured supportive care based on Swanson's Caring Theory or a control group receiving routine care. Outcomes were measured at baseline, after oocyte retrieval, and one month after embryo transfer.
| Arm | Type | Receives |
|---|---|---|
| Swanson-Based Supportive Care | Experimental | Behavioral: Swanson Caring Theory-based supportive careParticipants receive structured supportive care based on Swanson's Caring Theory, including education and counseling throughout the ART process. |
| Routine Care | No intervention | –Participants receive routine care provided by the IVF center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Couples diagnosed with primary infertility
- Aged 18 years or older
- Able to read and understand Turkish
- No diagnosed psychiatric disorder
- No communication problems or mental disability
Key exclusion criteria (4 listed)
- - No oocytes obtained during oocyte retrieval
- No sperm obtained from the male partner
- No embryo available for transfer
- Discontinuation of treatment during the study process
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 |
|---|---|---|
| Swanson Caring Theory-based supportive careA structured supportive care program based on Swanson's Caring Theory, including seven sessions of education, counseling, and emotional support delivered by a midwife to infertile couples throughout the ART process. The program was integrated into key treatment stages (ovarian stimulation, oocyte retrieval, and embryo transfer) and included both face-to-face and online sessions, focusing on reducing infertility-related stress and strengthening coping strategies. | Behavioural | Swanson-Based Supportive Care |
Primary outcome
Infertility-related stress
Time frame: Baseline, after oocyte retrieval, and 1 month after embryo transfer
Infertility-related stress assessed using the COMPI Fertility Problem Stress Scales, a 14-item multidimensional scale measuring personal, marital, and social aspects of infertility-related stress. Total scores range from 0 to 50, with higher scores indicating higher levels of infertility-related stress.
1 secondary outcome
Coping strategies
Time frame: Baseline, after oocyte retrieval, and 1 month after embryo transfer
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 5 May 2026.
- Derived from this study: PubMed 42613486Arslan B, Temiz S. A Swanson's caring theory-based intervention to reduce infertility-related stress and improve coping strategies in women and their partners undergoing assisted reproductive treatment (ART): a randomized controlled trial. Arch Womens Ment Health. 2026 Aug 19;29(5):115. doi: 10.1007/s00737-026-01750-x.
- Individual participant dataSharing planned: Undecided. Individual participant data are not publicly available due to ethical and confidentiality considerations but may be shared upon reasonable request, subject to approval by the relevant ethics committee.
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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 Swanson Caring Theory-based supportive care in people with Infertility, run by Ondokuz Mayıs 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 7 inclusion and 4 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 5 May 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?
Infertility-related stress (time frame: Baseline, after oocyte retrieval, and 1 month after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07557069, which also lists 1 linked publication.
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 5 May 2026.