NCT05663645

Brief 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. The investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of IVF benefits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

December 1, 2022

Last Update Submit

October 27, 2024

Conditions

Keywords

infertilityIVFhealth insurance

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 months after receipt of the intervention

Secondary Outcomes (5)

  • Health Insurance Literacy Measure

    1 month after receipt of the intervention

  • Utilization of IVF services

    10 months after receipt of the intervention

  • Insurance coverage

    10 months after receipt of the intervention

  • Out of pocket expenses

    10 months after receipt of the intervention

  • Financial hardship

    10 months after receipt of the intervention

Study Arms (2)

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.

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.

Interventions

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.

Health insurance educational guide

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • H. Irene Su, MD MSCE

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 23, 2022

Study Start

November 9, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Access Criteria
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).

Locations