Exploring reproductive health in adults with Fontan circulation
Fontan Circulation and Reproductive Health in a National Swedish Cohort
Linkoeping University · NCT06258382
This study looks at the reproductive health and fertility challenges faced by adults with Fontan circulation to see how it affects their relationships and pregnancy experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linkoeping University (other gov) |
| Locations | 15 sites (Lund, Skåne County and 14 other locations) |
| Trial ID | NCT06258382 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the reproductive health and fertility issues faced by adults with Fontan circulation, a complex congenital heart defect. It aims to assess the prevalence of sexual dysfunction and infertility among these patients and their partners, as well as the outcomes of pregnancy and delivery complications. Utilizing questionnaires and functional tests, the study will gather data from a national cohort of approximately 200 individuals with Fontan circulation and their partners. The research seeks to illuminate the psychosocial and medical factors affecting reproductive health in this population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Fontan circulation or their partners, as well as age- and gender-matched individuals without congenital heart disease.
Not a fit: Patients who do not have Fontan circulation or congenital heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into reproductive health challenges faced by patients with Fontan circulation, leading to improved care and support.
How similar studies have performed: While studies on congenital heart defects exist, this specific focus on reproductive health in Fontan patients is relatively novel and has not been extensively explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fontan circulation, * Age ≥18 years at inclusion, * Follow-up at specialist clinics, * Ability to fill in questionnaires in the Swedish language (no other alternative available) or * Partner of a person with Fontan circulation, * Age ≥18 years at inclusion * Ability to fill in questionnaires in the Swedish language (no other alternative available). or •Age- and gender-matched individuals are recruited via the population registry. They must not have congenital heart disease. Exclusion criteria: N/A \-
Where this trial is running
Lund, Skåne County and 14 other locations
- Lund University Skåne University Hospital — Lund, Skåne County, Sweden (RECRUITING)
- Sahlgrenska Academy, University of Gothenburg Sahlgrenska University Hospital — Gothenburg, Sweden (NOT_YET_RECRUITING)
- Sahlgrenska University Hospital, — Gothenburg, Sweden (NOT_YET_RECRUITING)
- University Hospital, Linköping — Linköping, Sweden (NOT_YET_RECRUITING)
- Skåne University Hospital, Lund University — Lund, Sweden (NOT_YET_RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (NOT_YET_RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (NOT_YET_RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (NOT_YET_RECRUITING)
- University West, Drottning Silvia's Children's Hospital/Sahlgrenska University Hospital, — Trollhättan, Sweden (NOT_YET_RECRUITING)
- Umeå University, Norrland University Hospital — Umeå, Sweden (NOT_YET_RECRUITING)
- Umeå University, Norrlands University Hospital — Umeå, Sweden (NOT_YET_RECRUITING)
- Umeå University, Norrlands University Hospital — Umeå, Sweden (NOT_YET_RECRUITING)
- Akademiska Hospital Uppsala.Uppsala University. — Uppsala, Sweden (RECRUITING)
- Uppsala University, Akademiska Hospital — Uppsala, Sweden (RECRUITING)
- Linköping University, University Hospital — Linköping, Östergötland County, Sweden (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Caroline Lilliecreutz, PhD, Docent
- Email: caroline.lilliecreutz@regionostergotland.se
- Phone: +46708731124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fontan Circulation, reproductive health, cognitive impairment, grown up heart disease