Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Sponsor
Hospital de Clinicas de Porto Alegre
Study ID
NCT06979063
Status
Not Yet Recruiting

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Conditions

  • Health Education
  • Infertility
  • Telehealth
  • Telemedicine

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 34 Years
Healthy Volunteers
Not accepted

Interventions

  • Remote Infertility Education and Counseling — OTHER
    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
    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.

Study Details

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.

Key Dates

First listed
May 18, 2025
Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
206 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Standard care
    Wait for specialized infertility consultation, following the usual health system process.
  • Experimental: intervention group
    Remote counseling and education about infertility and healthcare system navigation.

Primary Outcome Measure

Correct referral [ Time Frame: Six months after randomization ]

Central Contacts

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