Health Education for Women With Suspeced Infertility Waiting for Specialized Care

ConditionsInfertility Health Education Telemedicine Telehealth

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-34

SponsorHospital de Clinicas de Porto Alegre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals referred to specialized infertility care in Porto Alegre.

Age up to 33 years and 11 months.

Disqualifiers

Lack of access to the internet or telephone.

Prior specialized infertility treatment in the private healthcare system.

Trial design

Design model

Parallel

Treatments tested in this trial

Remote Infertility Education and Counseling
Other intervention
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.
Standard Care Arm
Other intervention
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.

Treatment groups

206 Participants

are divided into 2 treatment groups

Group A: Standard careActive comparator 1 intervention

Group B: intervention groupExperimental treatment 2 interventions

Trial outcomes