InfertilityNCT05663645
Navigating Health Insurance Selection for IVF Benefits
A study testing Health insurance educational guide in people with Infertility, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Health insurance educational guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Employees eligible for health insurance coverage
- Reproductive aged (18 to 50 years)
- Intention to grow their family in the next year
- Primary language English or Spanish
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: Navigating Health Insurance Selection for in Vitro Fertilization (IVF) Benefits
The purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits. The investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of IVF benefits.
- Conditions
- Infertility
- Being tested
- Health insurance educational guide
- Keywords
- infertility, IVF, health insurance
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health insurance educational guideBehavioural
The educational guide includes 4 content areas: 1) Definition of key insurance terms; 2) premiums, deductibles across the five 2023 health plans; 3) Summary of how premiums and deductibles can affect out of pocket costs; 4) Guide to finding in-network IVF providers and facilities.
| Study group | Role | What they receive |
|---|---|---|
| Health insurance educational guide | Experimental | Eligible individuals will receive a health insurance educational guide to support choosing among 5 health plans for IVF coverage. They will also receive receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period. Receives: Behavioral: Health insurance educational guide |
| Usual care | No intervention | Eligible individuals will receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Insurance Literacy Measure
9 items from the Health Insurance Literacy Measure will assess participants' confidence using their health insurance and being proactive with their health insurance for IVF services. Items will be scored from 0 (not at all confident) to 3 (very confident). Higher scores indicate better health insurance literacy.
Measured: 10 months after receipt of the intervention
Secondary outcomes (5)
Health Insurance Literacy Measure
6 items from the Health Insurance Literacy Measure will assess participants' likelihood of comparing health insurance plans. Items will be scored from 0 (not at all confident) to 3 (very confident). Higher scores indicate better health insurance literacy.
Measured: 1 month after receipt of the intervention
Utilization of IVF services
Participants will self-report utilization of IVF services.
Measured: 10 months after receipt of the intervention
Insurance coverage
Participants will self-report insurance coverage related to IVF services.
Measured: 10 months after receipt of the intervention
Out of pocket expenses
Participants will self-report out-of-pocket expenses related to IVF services.
Measured: 10 months after receipt of the intervention
Financial hardship
The 15-item Economic Strain and Resilience in Cancer tool will be used as a self-report subjective measure of financial hardship related to infertility and IVF services. Items are scored from 0 (least hardship) to 10 (most severe hardship). Higher scores indicate worse financial hardship.
Measured: 10 months after receipt of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start9 Nov 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Chun Irene Su, University of California, San Diego
- Investigators
- H. Irene Su, MD MSCE, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663645
- Sponsor's protocol ID
- 805955
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2022
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
Publications
Dayo O, Turcotte V, Reyes B, Flores Ortega RE, Kaiser BN, Aarons GA, McMenamin SB, Su HI, Romero SAD. Navigating health insurance selection for in vitro fertilization (IVF) benefits: A study protocol. Contemp Clin Trials. 2025 Aug;155:107998. doi: 10.1016/j.cct.2025.107998. Epub 2025 Jun 30.
PubMed 40602660
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating Health Insurance Selection for in Vitro Fertilization (IVF) Benefits
- ClinicalTrials.gov ID
- NCT05663645
- Acronym / sponsor ID
- 805955
- Conditions
- Infertility
- Keywords
- infertility, IVF, health insurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Dec 2022 (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.
The purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits. The investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of IVF benefits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Health insurance educational guide | Experimental | Behavioral: Health insurance educational guideEligible individuals will receive a health insurance educational guide to support choosing among 5 health plans for IVF coverage. They will also receive receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period. |
| Usual care | No intervention | –Eligible individuals will receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Employees eligible for health insurance coverage
- Reproductive aged (18 to 50 years)
- Intention to grow their family in the next year
- Primary language English or Spanish
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Health insurance educational guideThe educational guide includes 4 content areas: 1) Definition of key insurance terms; 2) premiums, deductibles across the five 2023 health plans; 3) Summary of how premiums and deductibles can affect out of pocket costs; 4) Guide to finding in-network IVF providers and facilities. | Behavioural | Health insurance educational guide |
Primary outcome
Health Insurance Literacy Measure
Time frame: 10 months after receipt of the intervention
9 items from the Health Insurance Literacy Measure will assess participants' confidence using their health insurance and being proactive with their health insurance for IVF services. Items will be scored from 0 (not at all confident) to 3 (very confident). Higher scores indicate better health insurance literacy.
5 secondary outcomes
Health Insurance Literacy Measure
Time frame: 1 month after receipt of the intervention
Utilization of IVF services
Time frame: 10 months after receipt of the intervention
Insurance coverage
Time frame: 10 months after receipt of the intervention
Out of pocket expenses
Time frame: 10 months after receipt of the intervention
Financial hardship
Time frame: 10 months after receipt of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Derived from this study: PubMed 40602660Dayo O, Turcotte V, Reyes B, Flores Ortega RE, Kaiser BN, Aarons GA, McMenamin SB, Su HI, Romero SAD. Navigating health insurance selection for in vitro fertilization (IVF) benefits: A study protocol. Contemp Clin Trials. 2025 Aug;155:107998. doi: 10.1016/j.cct.2025.107998. Epub 2025 Jun 30.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
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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. This study is not recruiting at the moment.
H. Irene Su, MD MSCE principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health insurance educational guide in people with Infertility, run by University of California, San Diego at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 30 Oct 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Insurance Literacy Measure (time frame: 10 months after receipt of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05663645, which also lists 1 linked publication.
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 30 Oct 2024.