Clinical Trial

Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT06979063
Lead Sponsor Hospital de Clinicas de Porto Alegre
Collaborators: Telessaúde RS
Conditions Infertility, Health Education, Telemedicine, Telehealth
Enrollment 206 participants
Start Date 2025-06
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-18