Infertility, Health Education, Telemedicine, Telehealth
Conditions
Brief summary
Introduction: Infertility is defined as a couple's inability to achieve pregnancy after 12 months or more of regular unprotected intercourse. In Brazil, it affects around eight million people. While health services provide resources for contraception, little attention is given to supporting conception and preserving fertility. Objective: To evaluate the effectiveness of a remote educational and counseling intervention on infertility. Method: Open-label randomized clinical trial. Couples referred for infertility will be identified in the electronic referral system. For inclusion, the woman of the couple must be 34 years old or less, no previous in-vitro fertilization attempts, and have access to telephone or internet. The control group will follow standard care, awaiting in-person consultation. The intervention group will also wait for in-person evaluation but receive additional education and counseling via video call. The primary outcome is the proportion of correct referrals according to local protocols. A total of 206 participants will be included to detect a difference between success rates of 50% and 30%, with 80% power and a 5% significance level.
Interventions
OTHERRemote Infertility Education and Counseling
Patients receive video call counseling covering infertility investigation, non-pharmacological fertility enhancement strategies, and healthcare navigation guidance. Health professionals review patient records and request missing infertility-related exams according to local protocol. Additional follow-ups occur approximately every 30 days to assist with pending investigations. If significant findings arise, patients will receive an explanation and assistance in scheduling primary care consultations.
OTHERStandard Care Arm
Referrals from patients will be avaluated following local protocols in the electronic referral system. Incomplete data will be requested through this system. There will be no direct contact with patients.
Sponsors
Telessaúde RS
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor and the statistician will be masked to group allocation. All other participants, investigators, and care providers will be aware of the assigned intervention.
Intervention model description
This is an open-label, superiority, randomized controlled trial with two parallel groups. Participants will be assigned to either a control group, which follows standard care, or an intervention group, which receives remote counseling and education about infertility and healthcare system navigation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
No
Inclusion criteria
* Individuals referred to specialized infertility care in Porto Alegre. * Age up to 33 years and 11 months.
Exclusion criteria
* Lack of access to the internet or telephone. * Prior specialized infertility treatment in the private healthcare system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct referral | Six months after randomization | Proportion of participants correctly referred to specialized care according to local protocols. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with conception plan achieved. | Six months after randomization | Patient-reported conception plan will be evaluated by interview to assess whether pregnancy was achieved or it was opted to forgo the plan. |
| FertiQoL | Six months after randomization | Change in Quality of Life as Measured by the Fertility Quality of Life (FertiQoL) Questionnaire. The FertiQoL is a validated instrument that measures quality of life in individuals experiencing fertility problems. Scores range from 0 to 100, where higher scores indicate better quality of life. |
| Time to regulation decision | Six months after randomization | Time in days between the referral and final decision for the referral |
| Time for in-person consulting | Six months after randomization | Time in days between the referral and in-person consult. |
Countries
Brazil
Contacts
Primary ContactMichele Strelow Moreira
Backup ContactHelena von Eye Corleta
Outcome results
None listed