InfertilityPCCSNCT06068634
Patient-Centered Care Survey
An observational study of Infertility, run by Inception Fertility Research Institute, LLC at 1 site in United States.
Trial summary
The key to patient-centered care is to identify what the patient perceives as meaningful. The primary objective of this research is to evaluate which aspects of patient-centered care are priorities to infertility patients, and if those priorities vary by geographical region. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 24 Apr 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infertility patients who have had any type of visit at a participating clinic within the last 6 months of the date of study initiation. Participating clinics are United States based fertility clinics who are part of The Prelude Network. This includes 10 fertility practices, consisting of approximately 40 individual locations.
Who may be able to join
- Current patient within The Prelude Network (a network of fertility clinics).
- Has had any type of visit at a participating clinic within the last 6 months of the date of study initiation.
Who cannot join
- Not a current patient at a participating clinic.
- Has not had an appointment within 6 months of the date of study initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-Centered Care Survey of Infertility Patients
The key to patient-centered care is to identify what the patient perceives as meaningful. The primary objective of this research is to evaluate which aspects of patient-centered care are priorities to infertility patients, and if those priorities vary by geographical region.
Read the detailed description
An electronic survey will be distributed to current patients within The Prelude Network, a network of fertility practices, for a total of six months. Survey responses will be collected anonymously using Survey Monkey. The survey is designed to collect information on patient preferences for patient-centered care. Participants will rank the importance of the different options within each Factor category (Clinic, Physician, Finance, and Staff). In addition, demographic questions are included and will be utilized to determine if these factors could have a significant impact on patient-centered care preferences. It is anticipated that at least 1,000 completed surveys will be collected. A similar survey was distributed to Prelude Network physicians. Patient and physician responses may be compared as part of additional data analysis.
- Conditions
- Infertility
- Keywords
- Patient-centered care, Patient experience
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Current Patients | Current patient is defined as any patient who has had any type of visit at a participating clinic within the last 6 months of the date of study initiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Analysis
Descriptive analyses of survey results.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start23 Oct 2023
- Primary completion24 Jan 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
- Investigators
- Alice Domar, PhD, Principal investigator, Inception Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068634
- Sponsor's protocol ID
- FER-CSS-2023-0248
- Acronym
- PCCS
- Status last verified
- Aug 2024
- First submitted
- 29 Sep 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen TH, Chang SP, Tsai CF, Juang KD. Prevalence of depressive and anxiety disorders in an assisted reproductive technique clinic. Hum Reprod. 2004 Oct;19(10):2313-8. doi: 10.1093/humrep/deh414. Epub 2004 Jul 8.
PubMed 15242992den Breejen EM, Nelen WL, Schol SF, Kremer JA, Hermens RP. Development of guideline-based indicators for patient-centredness in fertility care: what patients add. Hum Reprod. 2013 Apr;28(4):987-96. doi: 10.1093/humrep/det010. Epub 2013 Feb 14.
PubMed 23411619Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
PubMed 26072382Domar AD, Rooney K, Hacker MR, Sakkas D, Dodge LE. Burden of care is the primary reason why insured women terminate in vitro fertilization treatment. Fertil Steril. 2018 Jun;109(6):1121-1126. doi: 10.1016/j.fertnstert.2018.02.130.
PubMed 29935647Garcia D, Bautista O, Venereo L, Coll O, Vassena R, Vernaeve V. Training in empathic skills improves the patient-physician relationship during the first consultation in a fertility clinic. Fertil Steril. 2013 Apr;99(5):1413-1418.e1. doi: 10.1016/j.fertnstert.2012.12.012. Epub 2013 Jan 5.
PubMed 23294674Huppelschoten AG, Aarts JW, van Empel IW, Cohlen BJ, Kremer JA, Nelen WL. Feedback to professionals on patient-centered fertility care is insufficient for improvement: a mixed-method study. Fertil Steril. 2013 Apr;99(5):1419-27. doi: 10.1016/j.fertnstert.2012.12.024. Epub 2013 Jan 26.
PubMed 23357454Pasch LA, Holley SR, Bleil ME, Shehab D, Katz PP, Adler NE. Addressing the needs of fertility treatment patients and their partners: are they informed of and do they receive mental health services? Fertil Steril. 2016 Jul;106(1):209-215.e2. doi: 10.1016/j.fertnstert.2016.03.006. Epub 2016 Mar 24.
PubMed 27018159Troude P, Ancelet S, Guibert J, Pouly JL, Bouyer J, de La Rochebrochard E. Joint modeling of success and treatment discontinuation in in vitro fertilization programs: a retrospective cohort study. BMC Pregnancy Childbirth. 2012 Aug 3;12:77. doi: 10.1186/1471-2393-12-77.
PubMed 22862824Troude P, Guibert J, Bouyer J, de La Rochebrochard E; DAIFI Group. Medical factors associated with early IVF discontinuation. Reprod Biomed Online. 2014 Mar;28(3):321-9. doi: 10.1016/j.rbmo.2013.10.018. Epub 2013 Oct 31.
PubMed 24461478van Empel IW, Dancet EA, Koolman XH, Nelen WL, Stolk EA, Sermeus W, D'Hooghe TM, Kremer JA. Physicians underestimate the importance of patient-centredness to patients: a discrete choice experiment in fertility care. Hum Reprod. 2011 Mar;26(3):584-93. doi: 10.1093/humrep/deq389. Epub 2011 Jan 12.
PubMed 21227936
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Care Survey of Infertility Patients
- ClinicalTrials.gov ID
- NCT06068634
- Acronym / sponsor ID
- PCCS / FER-CSS-2023-0248
- Conditions
- Infertility
- Keywords
- Patient-centered care, Patient experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- EMD Serono
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 5 Oct 2023 (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 key to patient-centered care is to identify what the patient perceives as meaningful. The primary objective of this research is to evaluate which aspects of patient-centered care are priorities to infertility patients, and if those priorities vary by geographical region.
Detailed description
An electronic survey will be distributed to current patients within The Prelude Network, a network of fertility practices, for a total of six months. Survey responses will be collected anonymously using Survey Monkey. The survey is designed to collect information on patient preferences for patient-centered care. Participants will rank the importance of the different options within each Factor category (Clinic, Physician, Finance, and Staff). In addition, demographic questions are included and will be utilized to determine if these factors could have a significant impact on patient-centered care preferences. It is anticipated that at least 1,000 completed surveys will be collected. A similar survey was distributed to Prelude Network physicians. Patient and physician responses may be compared as part of additional data analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Current Patients | – | –Current patient is defined as any patient who has had any type of visit at a participating clinic within the last 6 months of the date of study initiation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infertility patients who have had any type of visit at a participating clinic within the last 6 months of the date of study initiation. Participating clinics are United States based fertility clinics who are part of The Prelude Network. This includes 10 fertility practices, consisting of approximately 40 individual locations.
Key inclusion criteria (2 listed)
- Current patient within The Prelude Network (a network of fertility clinics).
- Has had any type of visit at a participating clinic within the last 6 months of the date of study initiation.
Key exclusion criteria (2 listed)
- Not a current patient at a participating clinic.
- Has not had an appointment within 6 months of the date of study initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive Analysis
Time frame: 6 months
Descriptive analyses of survey results.
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 22 Aug 2024.
- Background: PubMed 15242992Chen TH, Chang SP, Tsai CF, Juang KD. Prevalence of depressive and anxiety disorders in an assisted reproductive technique clinic. Hum Reprod. 2004 Oct;19(10):2313-8. doi: 10.1093/humrep/deh414. Epub 2004 Jul 8.
- Background: PubMed 23411619den Breejen EM, Nelen WL, Schol SF, Kremer JA, Hermens RP. Development of guideline-based indicators for patient-centredness in fertility care: what patients add. Hum Reprod. 2013 Apr;28(4):987-96. doi: 10.1093/humrep/det010. Epub 2013 Feb 14.
- Background: PubMed 26072382Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
- Background: PubMed 29935647Domar AD, Rooney K, Hacker MR, Sakkas D, Dodge LE. Burden of care is the primary reason why insured women terminate in vitro fertilization treatment. Fertil Steril. 2018 Jun;109(6):1121-1126. doi: 10.1016/j.fertnstert.2018.02.130.
- Background: PubMed 23294674Garcia D, Bautista O, Venereo L, Coll O, Vassena R, Vernaeve V. Training in empathic skills improves the patient-physician relationship during the first consultation in a fertility clinic. Fertil Steril. 2013 Apr;99(5):1413-1418.e1. doi: 10.1016/j.fertnstert.2012.12.012. Epub 2013 Jan 5.
- Background: PubMed 23357454Huppelschoten AG, Aarts JW, van Empel IW, Cohlen BJ, Kremer JA, Nelen WL. Feedback to professionals on patient-centered fertility care is insufficient for improvement: a mixed-method study. Fertil Steril. 2013 Apr;99(5):1419-27. doi: 10.1016/j.fertnstert.2012.12.024. Epub 2013 Jan 26.
- Background: PubMed 27018159Pasch LA, Holley SR, Bleil ME, Shehab D, Katz PP, Adler NE. Addressing the needs of fertility treatment patients and their partners: are they informed of and do they receive mental health services? Fertil Steril. 2016 Jul;106(1):209-215.e2. doi: 10.1016/j.fertnstert.2016.03.006. Epub 2016 Mar 24.
- Background: PubMed 22862824Troude P, Ancelet S, Guibert J, Pouly JL, Bouyer J, de La Rochebrochard E. Joint modeling of success and treatment discontinuation in in vitro fertilization programs: a retrospective cohort study. BMC Pregnancy Childbirth. 2012 Aug 3;12:77. doi: 10.1186/1471-2393-12-77.
- Background: PubMed 24461478Troude P, Guibert J, Bouyer J, de La Rochebrochard E; DAIFI Group. Medical factors associated with early IVF discontinuation. Reprod Biomed Online. 2014 Mar;28(3):321-9. doi: 10.1016/j.rbmo.2013.10.018. Epub 2013 Oct 31.
- Background: PubMed 21227936van Empel IW, Dancet EA, Koolman XH, Nelen WL, Stolk EA, Sermeus W, D'Hooghe TM, Kremer JA. Physicians underestimate the importance of patient-centredness to patients: a discrete choice experiment in fertility care. Hum Reprod. 2011 Mar;26(3):584-93. doi: 10.1093/humrep/deq389. Epub 2011 Jan 12.
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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.
Alice Domar, PhD principal investigator
Inception Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Inception Fertility Research Institute, LLC 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 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: finished, as of the sponsor's last update on 22 Aug 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?
Descriptive Analysis (time frame: 6 months). 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 NCT06068634, which also lists 10 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 22 Aug 2024.