Health Education for Women With Suspeced Infertility Waiting for Specialized Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Infertility Education and Counseling, Standard Care Arm.
- Who it may be relevant to
- Registry conditions: Infertility, Health Education, Telemedicine, Telehealth. Basic parameters: 18 years — 34 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Regulation Strategies and Health Education for Managing Infertility in Primary Health Care in Rio Grande do Sul
Overview
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
- Other Remote 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 consulta - Other Standard 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.
Primary outcome measures
- Correct referral [Time frame: Six months after randomization]
Secondary outcome measures (4)
- Proportion of patients with conception plan achieved. [Time frame: Six months after randomization]
- FertiQoL [Time frame: Six months after randomization]
- Time to regulation decision [Time frame: Six months after randomization]
- Time for in-person consulting [Time frame: Six months after randomization]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre (HCPA) — Porto Alegre
Identifiers
NCT: NCT06979063 · 2022-0588