Oocyte Donor Application Discrepancies

Inception Fertility Research Institute, LLC

Status: Completed

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 (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.

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: 600 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