Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Официальное название

Impact of Regulation Strategies and Health Education for Managing Infertility in Primary Health Care in Rio Grande do Sul

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Correct referral [Срок оценки: Six months after randomization]

Вторичные конечные точки (4)

• Proportion of patients with conception plan achieved. [Срок оценки: Six months after randomization]
• FertiQoL [Срок оценки: Six months after randomization]
• Time to regulation decision [Срок оценки: Six months after randomization]
• Time for in-person consulting [Срок оценки: Six months after randomization]

Критерии участия

Критерии включения

• Individuals referred to specialized infertility care in Porto Alegre.
• Age up to 33 years and 11 months.

Критерии исключения

• Lack of access to the internet or telephone.
• Prior specialized infertility treatment in the private healthcare system.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 1 центр

• Hospital de Clínicas de Porto Alegre (HCPA) — Porto Alegre

Идентификаторы

NCT: NCT06979063 · 2022-0588

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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