NCT06068634

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

September 29, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

September 29, 2023

Last Update Submit

August 20, 2024

Conditions

Keywords

Patient-centered carePatient experience

Outcome Measures

Primary Outcomes (1)

  • Descriptive Analysis

    Descriptive analyses of survey results.

    6 months

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Not a current patient at a participating clinic.
  • Has not had an appointment within 6 months of the date of study initiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inception Fertility, LLC

Houston, Texas, 77081, United States

Location

Related Publications (10)

  • 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.

    PMID: 15242992BACKGROUND
  • den 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.

    PMID: 23411619BACKGROUND
  • Domar 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.

    PMID: 26072382BACKGROUND
  • Domar 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.

    PMID: 29935647BACKGROUND
  • Garcia 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.

    PMID: 23294674BACKGROUND
  • Huppelschoten 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.

    PMID: 23357454BACKGROUND
  • Pasch 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.

    PMID: 27018159BACKGROUND
  • Troude 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.

    PMID: 22862824BACKGROUND
  • Troude 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.

    PMID: 24461478BACKGROUND
  • van 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.

    PMID: 21227936BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Alice Domar, PhD

    Inception Fertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 5, 2023

Study Start

October 23, 2023

Primary Completion

January 24, 2024

Study Completion

April 24, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations