Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-34
SponsorHospital de Clinicas de Porto Alegre

About this trial

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.

Eligibility criteria

Qualifiers

Individuals referred to specialized infertility care in Porto Alegre.

Age up to 33 years and 11 months.

Disqualifiers

Lack of access to the internet or telephone.

Prior specialized infertility treatment in the private healthcare system.

Trial design

Treatments tested in this trial

  • Remote Infertility Education and Counseling
  • Standard Care Arm

Treatment groups

206 Participants
are divided into 2 treatment groups

Sponsors and collaborators