Health Education for Women With Suspeced Infertility Waiting for Specialized Care

NCT06979063 | Not Yet Recruiting

• 1 other identifier: 2022-0588
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Health Education; Telemedicine; Telehealth

Outcome Measures

Primary Outcomes (1)

• Correct referral

  Proportion of participants correctly referred to specialized care according to local protocols.

  Six months after randomization

Secondary Outcomes (4)

• Proportion of patients with conception plan achieved.

  Six months after randomization

• FertiQoL

  Six months after randomization

• Time to regulation decision

  Six months after randomization

• Time for in-person consulting

  Six months after randomization

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Wait for specialized infertility consultation, following the usual health system process.

Other: Standard Care Arm

intervention group

EXPERIMENTAL

Remote counseling and education about infertility and healthcare system navigation.

Other: Remote Infertility Education and Counseling; Other: Standard Care Arm

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.

intervention group

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.

Standard care; intervention group

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Telessaúde RS: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Infertility; Health Education

Interventions

Counseling

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Michele Strelow Moreira

CONTACT

+5551992607430; mstrelowmoreira@gmail.com

Helena von Eye Corleta

CONTACT

51999862749; hcorleta@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor and the statistician will be masked to group allocation. All other participants, investigators, and care providers will be aware of the assigned intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an open-label, superiority, randomized controlled trial with two parallel groups. Participants will be assigned to either a control group, which follows standard care, or an intervention group, which receives remote counseling and education about infertility and healthcare system navigation.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 18, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

BR (1)