Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06979063

Health Education for Women With Suspeced Infertility Waiting for Specialized Care

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre (HCPA)

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Correct referral

    Time frame: Six months after randomization

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

Secondary outcomes

  1. Proportion of patients with conception plan achieved.

    Time frame: 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.

  2. FertiQoL

    Time frame: 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.

  3. Time to regulation decision

    Time frame: Six months after randomization

    Time in days between the referral and final decision for the referral

  4. Time for in-person consulting

    Time frame: Six months after randomization

    Time in days between the referral and in-person consult.

Study contacts

Contact information is provided by the study sponsor or research team.

Helena von Eye Corleta

CONTACT

[email protected]

51999862749

Michele Strelow Moreira

CONTACT

[email protected]

+5551992607430

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Telessaúde RS

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.