InfertilityImpaLaNCT06636838
Language Matters: Exploring the Impact of Language Concordance on Fertility Treatment Progression
A study testing Spanish-Speaking Provider in people with Infertility and Infertility (IVF Patients), run by Washington University School of Medicine at 1 site in United States.
Trial summary
Currently, patients presenting to the Fertility and Reproductive Medicine Center meet with an English-speaking provider and communicate through an interpreter, as none of the physicians speak Spanish. However, this study PI is a native Spanish speaker and certified bilingual clinician. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Infertility (IVF Patients), Infertility Assisted Reproductive Technology
- What is being tested?
- Spanish-Speaking Provider
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 30 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be greater than 18 years old
- Preferred language must be Spanish speaking
- Must be seeking fertility treatment
Who cannot join
- Preferred language English
- Not currently seeking fertility care
- Less than 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University in St Louis
St Louis, Missouri, 63108
Aileen Portugal, MD, 619-993-4298, aileenp@wustl.edu
Aileen Portugal, MD
About this study
Currently, patients presenting to the Fertility and Reproductive Medicine Center meet with an English-speaking provider and communicate through an interpreter, as none of the physicians speak Spanish. However, this study PI is a native Spanish speaker and certified bilingual clinician. Thus, this study is looking to evaluate whether or not the use of an interpreter delays completion of testing and initiation of fertility treatment. The medically indicated testing, procedures, and course of treatment will not be altered as a result of participation in the study. Participants will be asked to complete a survey in their preferred language to gauge satisfaction and communication efficacy.
This proposed study is significant as it seeks to address a critical gap in the understanding of how language concordance between healthcare providers and patients influences treatment outcomes in fertility care. With Spanish being the most commonly spoken non-English language in the U.S., evaluating the impact of Spanish language skills in medical care is both timely and essential. This research will shed light on whether Spanish-speaking patients experience better treatment progression and outcomes when cared for by language-concordant providers versus when interpreters are used in fertility care.
This prospective study will be conducted at Washington University's Fertility and Reproductive Medicine Center over a 12-month period. The investigators aim to enroll a total of 70 Spanish-speaking patients, based on previous patient trends at the Center 35 will be randomized to the intervention group (being evaluated and treated by a Spanish-speaking provider), and 35 will be randomized to standard of care (communicating with an English-speaking provider through an interpreter).
- Conditions
- Infertility, Infertility (IVF Patients), Infertility Assisted Reproductive Technology, Ovulation Ind
- Being tested
- Spanish-Speaking Provider
- Keywords
- Spanish speaking, Spanish, infertility, Infertility work-up, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish-Speaking ProviderBehavioural
Spanish speaking patients will be seen by our Spanish-speaking provider
| Study group | Role | What they receive |
|---|---|---|
| Spanish speaking patients seen by English-Speaking Provider | No intervention | Spanish speaking patients will be seen by our English-speaking providers using a qualified interpreter. |
| Spanish-Speaking patients seen by a Spanish-speaking provider | Experimental | Spanish speaking patients will be seen by our Spanish-speaking provider Receives: Behavioral: Spanish-Speaking Provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of diagnostic tests
The primary outcome is the time from the patients initial consultation to the completion of the recommended fertility diagnostic tests such as blood work or a pelvic ultrasound. Given that the tests are typically specific to the menstrual cycle, the investigators want know if the patients are completing their work-up faster when they see a Spanish-speaking physician thus understanding the instructions versus when the English speaking providers use an interpreter. The work-up only includes the labs and imaging that was recommended during their initial visit. The outcome will be measured by the unit - days.
Measured: 90 days from initial consultation.
Secondary outcomes (1)
Patient satisfaction and communication
Patient satisfaction and communication effectiveness, assessed through surveys administered after the initial consultation. The survey is a validated survey that uses a point system metric to conclude patient satisfaction similar to the PHQ-9 survey.
Measured: 90 days from initial consultation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636838
- Sponsor's protocol ID
- IRB ID #: 202407176
- Acronym
- ImpaLa
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jain M, Peterson A, Nguyen N, Goldsammler M. Reproductive inequity and inferior intrauterine insemination outcomes in patients with limited English proficiency: a retrospective cohort study. Fertil Steril. 2023 Oct;120(4):844-849. doi: 10.1016/j.fertnstert.2023.05.154. Epub 2023 May 22.
PubMed 37225071Lopez Vera A, Thomas K, Trinh C, Nausheen F. A Case Study of the Impact of Language Concordance on Patient Care, Satisfaction, and Comfort with Sharing Sensitive Information During Medical Care. J Immigr Minor Health. 2023 Dec;25(6):1261-1269. doi: 10.1007/s10903-023-01463-8. Epub 2023 Feb 25.
PubMed 36840903Berdahl TA, Kirby JB. Patient-Provider Communication Disparities by Limited English Proficiency (LEP): Trends from the US Medical Expenditure Panel Survey, 2006-2015. J Gen Intern Med. 2019 Aug;34(8):1434-1440. doi: 10.1007/s11606-018-4757-3. Epub 2018 Dec 3.
PubMed 30511285
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language Matters: Exploring the Impact of Language Concordance on Fertility Treatment Progression
- ClinicalTrials.gov ID
- NCT06636838
- Acronym / sponsor ID
- ImpaLa / IRB ID #: 202407176
- Conditions
- Infertility, Infertility (IVF Patients), Infertility Assisted Reproductive Technology, Ovulation Ind
- Keywords
- Spanish speaking, Spanish, infertility, Infertility work-up, IVF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Currently, patients presenting to the Fertility and Reproductive Medicine Center meet with an English-speaking provider and communicate through an interpreter, as none of the physicians speak Spanish. However, this study PI is a native Spanish speaker and certified bilingual clinician. Thus, this study is looking to evaluate whether or not the use of an interpreter delays completion of testing and initiation of fertility treatment. The medically indicated testing, procedures, and course of treatment will not be altered as a result of participation in the study. Participants will be asked to complete a survey in their preferred language to gauge satisfaction and communication efficacy.
This proposed study is significant as it seeks to address a critical gap in the understanding of how language concordance between healthcare providers and patients influences treatment outcomes in fertility care. With Spanish being the most commonly spoken non-English language in the U.S., evaluating the impact of Spanish language skills in medical care is both timely and essential. This research will shed light on whether Spanish-speaking patients experience better treatment progression and outcomes when cared for by language-concordant providers versus when interpreters are used in fertility care.
This prospective study will be conducted at Washington University's Fertility and Reproductive Medicine Center over a 12-month period. The investigators aim to enroll a total of 70 Spanish-speaking patients, based on previous patient trends at the Center 35 will be randomized to the intervention group (being evaluated and treated by a Spanish-speaking provider), and 35 will be randomized to standard of care (communicating with an English-speaking provider through an interpreter).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spanish speaking patients seen by English-Speaking Provider | No intervention | –Spanish speaking patients will be seen by our English-speaking providers using a qualified interpreter. |
| Spanish-Speaking patients seen by a Spanish-speaking provider | Experimental | Behavioral: Spanish-Speaking ProviderSpanish speaking patients will be seen by our Spanish-speaking provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be greater than 18 years old
- Preferred language must be Spanish speaking
- Must be seeking fertility treatment
Key exclusion criteria (3 listed)
- Preferred language English
- Not currently seeking fertility care
- Less than 18 years old
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 |
|---|---|---|
| Spanish-Speaking ProviderSpanish speaking patients will be seen by our Spanish-speaking provider | Behavioural | Spanish-Speaking patients seen by a Spanish-speaking provider |
Primary outcome
Completion of diagnostic tests
Time frame: 90 days from initial consultation.
The primary outcome is the time from the patients initial consultation to the completion of the recommended fertility diagnostic tests such as blood work or a pelvic ultrasound. Given that the tests are typically specific to the menstrual cycle, the investigators want know if the patients are completing their work-up faster when they see a Spanish-speaking physician thus understanding the instructions versus when the English speaking providers use an interpreter. The work-up only includes the labs and imaging that was recommended during their initial visit. The outcome will be measured by the unit - days.
1 secondary outcome
Patient satisfaction and communication
Time frame: 90 days from initial consultation.
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 28 Mar 2025.
- Background: PubMed 37225071Jain M, Peterson A, Nguyen N, Goldsammler M. Reproductive inequity and inferior intrauterine insemination outcomes in patients with limited English proficiency: a retrospective cohort study. Fertil Steril. 2023 Oct;120(4):844-849. doi: 10.1016/j.fertnstert.2023.05.154. Epub 2023 May 22.
- Background: PubMed 36840903Lopez Vera A, Thomas K, Trinh C, Nausheen F. A Case Study of the Impact of Language Concordance on Patient Care, Satisfaction, and Comfort with Sharing Sensitive Information During Medical Care. J Immigr Minor Health. 2023 Dec;25(6):1261-1269. doi: 10.1007/s10903-023-01463-8. Epub 2023 Feb 25.
- Background: PubMed 30511285Berdahl TA, Kirby JB. Patient-Provider Communication Disparities by Limited English Proficiency (LEP): Trends from the US Medical Expenditure Panel Survey, 2006-2015. J Gen Intern Med. 2019 Aug;34(8):1434-1440. doi: 10.1007/s11606-018-4757-3. Epub 2018 Dec 3.
- Language Use in the United States: 2019Link provided by the sponsor.
- 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 Spanish-Speaking Provider in people with Infertility and Infertility (IVF Patients), run by Washington University School of Medicine 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Mar 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 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?
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 Aileen Portugal, MD (619-993-4298, aileenp@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of diagnostic tests (time frame: 90 days from initial consultation.). 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 NCT06636838, which also lists 3 linked publications.
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 28 Mar 2025.