InfertilityNCT06979063
Health Education for Women With Suspeced Infertility Waiting for Specialized Care
A study testing Remote Infertility Education and Counseling in people with Infertility and Health Education, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Infertility, Health Education, Telemedicine
- What is being tested?
- Remote Infertility Education and Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals referred to specialized infertility care in Porto Alegre.
- Age up to 33 years and 11 months.
Who cannot join
- Lack of access to the internet or telephone.
- Prior specialized infertility treatment in the private healthcare system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Impact of Regulation Strategies and Health Education for Managing Infertility in Primary Health Care in Rio Grande do Sul
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.
Read more
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.
- Conditions
- Infertility, Health Education, Telemedicine, Telehealth
- Being tested
- Remote Infertility Education and Counseling, Standard Care Arm
- Medical subject headings
- Infertility, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Infertility Education and CounselingOther
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.
Standard Care ArmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Wait for specialized infertility consultation, following the usual health system process. Receives: Other: Standard Care Arm |
| intervention group | Experimental | Remote counseling and education about infertility and healthcare system navigation. Receives: Other: Remote Infertility Education and Counseling; Other: Standard Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct referral
Proportion of participants correctly referred to specialized care according to local protocols.
Measured: Six months after randomization
Secondary outcomes (4)
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.
Measured: 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.
Measured: Six months after randomization
Time to regulation decision
Time in days between the referral and final decision for the referral
Measured: Six months after randomization
Time for in-person consulting
Time in days between the referral and in-person consult.
Measured: Six months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study startJun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Telessaúde RS
- Responsible party
- Principal investigator, Michele Zschornack Strelow, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979063
- Sponsor's protocol ID
- 2022-0588
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regulation Strategies and Health Education for Managing Infertility in Primary Health Care in Rio Grande do Sul
- ClinicalTrials.gov ID
- NCT06979063
- Acronym / sponsor ID
- 2022-0588
- Conditions
- Infertility, Health Education, Telemedicine, Telehealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Telessaúde RS
- Study start
- Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard Care ArmWait for specialized infertility consultation, following the usual health system process. |
| intervention group | Experimental | Other: Remote Infertility Education and Counseling, Other: Standard Care ArmRemote counseling and education about infertility and healthcare system navigation. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals referred to specialized infertility care in Porto Alegre.
- Age up to 33 years and 11 months.
Key exclusion criteria (2 listed)
- Lack of access to the internet or telephone.
- Prior specialized infertility treatment in the private healthcare system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Infertility Education and CounselingPatients 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. | Other | intervention group |
| Standard Care ArmReferrals 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. | Other | Standard care, intervention group |
Primary outcome
Correct referral
Time frame: Six months after randomization
Proportion of participants correctly referred to specialized care according to local protocols.
4 secondary outcomes
Proportion of patients with conception plan achieved.
Time frame: Six months after randomization
FertiQoL
Time frame: Six months after randomization
Time to regulation decision
Time frame: Six months after randomization
Time for in-person consulting
Time frame: Six months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Infertility Education and Counseling in people with Infertility and Health Education, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Strelow Moreira (+5551992607430, mstrelowmoreira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct referral (time frame: Six months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.