Oocyte Donor Application Discrepancies

Inception Fertility, LLC

Status: Active, not recruiting

Conditions: Infertility

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06362551

INC-GS-2024-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No 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