Oocyte Donor Application Discrepancies

Retrospective Analysis of Differences in Information Provided by Donor Applicants Obtained by Written Application Compared to Genetic Risk Assessment Performed by Certified Genetic Counselor as Part of Routine Screening Process

Retrospective observational study comparing information received on Inception Central Donor Recruitment's standardized online egg donor application compared to information reported during a genetic risk assessment consultation with a certified genetic counselor with contracted third party genetic counseling service, GeneScreen. All donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility

Detailed Description

Background: Historically, it has been considered sufficient to have an egg donor applicant complete a written application that is reviewed by an egg donor program for acceptability. In 2021, ASRM put forth recommendations that "family history review and assessment of donors should be performed by a certified genetic counselor". In 2022, Inception Central Donor Recruitment (CDR) established a process for screening donor applicants that included genetic risk assessment (GRA) with a certified genetic counselor. This study seeks to illustrate the discrepancies between personal and family history information documented on a standardized online application compared to a GRA consultation with a certified genetic counselor.

Objectives: Investigate the rate of new information obtained at GRA which was not included in the full application, as follows:

• New information with no change to health risk assessment (i.e. change in number of relatives)

• New information with a change to health risk assessment (i.e. known or suspected diagnoses for OD or family), with one of the following decisions

  • Still acceptable/approved for clinic (ie new multifactorial condition reported, such as diabetes)
  • Decline based on TPN internal guidelines alone (ie meets NCCN criteria for genetic testing)
  • Decline based on ASRM guidelines (ie first degree relative with a major malformation)

Hypothesis: Information obtained through GRA with a certified genetic counselor will lead to more detailed and accurate assessment of donor applicant eligibility. Some information obtained through GRA, which was not apparent on application, will lead to a donor applicant being declined based on internal Prelude Network Donor Screening Guidelines and/or guidelines set forth by the American Society of Reproductive Medicine.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77081
      • Inception Fertility LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Oocyte donors

Description

Inclusion Criteria:

• All oocyte donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of additional information	Simple statistical calculations will be evaluated for rate of additional information identified.	6 months
Rate of applicant decline	Simple statistical calculations will be evaluated for rate of applicant decline based on new information.	6 months

Collaborators and Investigators

• Sponsor: Inception Fertility, LLC
• Collaborators: GeneScreen Counseling, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: INC-GS-2024-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No