An interventional study of Remote Infertility Education and Counseling and Standard Care Arm in Infertility, Health Education and Telemedicine, sponsored by Hospital de Clinicas de Porto Alegre. Not yet recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Health services research
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 206 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Wait for specialized infertility consultation, following the usual health system process.
Other: Standard Care Arm
Remote counseling and education about infertility and healthcare system navigation.
Other: Remote Infertility Education and Counseling · Other: Standard Care Arm
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.
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.
Correct referral
Proportion of participants correctly referred to specialized care according to local protocols.
Time frame: Six months after randomization
Proportion of patients with conception plan achieved.
Patient-reported conception plan will be evaluated by interview to assess whether pregnancy was achieved or it was opted to forgo the plan.
Time frame: Six months after randomization
FertiQoL
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.
Time frame: Six months after randomization
Time to regulation decision
Time in days between the referral and final decision for the referral
Time frame: Six months after randomization
Time for in-person consulting
Time in days between the referral and in-person consult.
Time frame: Six months after randomization
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre