Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Not Applicable

Not yet recruiting

• Conditions: Infertility; Telehealth; Health Education; Telemedicine

• Registration Number: NCT06979063
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-24
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Correct referral	Six months after randomization	Proportion of participants correctly referred to specialized care according to local protocols.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre (HCPA); 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil