Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Hospital de Clinicas de Porto Alegre

Status: Not yet enrolling

Conditions: Infertility; Telemedicine; Telehealth; Health Education

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06979063

2022-0588

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care Arm

intervention group

Experimental group

Description:

Remote counseling and education about infertility and healthcare system navigation.

Treatment:

Other: Remote Infertility Education and Counseling

Other: Standard Care Arm