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| Name | Class |
|---|---|
| Telessaúde RS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Wait for specialized infertility consultation, following the usual health system process. |
|
| intervention group | Experimental | Remote counseling and education about infertility and healthcare system navigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correct referral | Proportion of participants correctly referred to specialized care according to local protocols. | Six months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months after randomization |
| FertiQoL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Strelow Moreira | Contact | +5551992607430 | mstrelowmoreira@gmail.com | |
| Helena von Eye Corleta | Contact | 51999862749 | hcorleta@hcpa.edu.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre (HCPA) | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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This is an open-label, superiority, randomized controlled trial with two parallel groups. Participants will be assigned to either a control group, which follows standard care, or an intervention group, which receives remote counseling and education about infertility and healthcare system navigation.
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The outcomes assessor and the statistician will be masked to group allocation. All other participants, investigators, and care providers will be aware of the assigned intervention.
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| 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. |
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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.
| Six months after randomization |
| Time to regulation decision | Time in days between the referral and final decision for the referral | Six months after randomization |
| Time for in-person consulting | Time in days between the referral and in-person consult. | Six months after randomization |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D005159 | Health Care Facilities Workforce and Services |