Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
NCT Number: NCT06979063
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.
Trial opening soon.
Get Notified18 year–34 year
Female
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Six months after randomization
Proportion of participants correctly referred to specialized care according to local protocols.
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.
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.
Time frame: Six months after randomization
Time in days between the referral and final decision for the referral
Time frame: Six months after randomization
Time in days between the referral and in-person consult.
Contact information is provided by the study sponsor or research team.
Helena von Eye Corleta
CONTACT
Michele Strelow Moreira
CONTACT
Hospital de Clinicas de Porto Alegre
Other
Impact of Regulation Strategies and Health Education for Managing Infertility in Primary Health Care in Rio Grande do Sul
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.
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