CompletedNot Applicable

Swanson-Based Supportive Care for Infertility Stress and Coping in Couples Undergoing ART

Turkey (Türkiye)50 participantsStarted 2022-07-05

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion Criteria: * 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) Exclusion Criteria: * \- 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infertility-related stress

Timeframe: Baseline, after oocyte retrieval, and 1 month after embryo transfer

Trial details

NCT IDNCT07557069

SponsorOndokuz Mayıs University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-05

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