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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06362551

Enrollment

600

Registered

2024-04-12

Start date

2024-03-25

Completion date

2024-04-24

Last updated

2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

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 (GRA) 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results