Oocyte Donor Application Discrepancies
- Conditions
- Infertility
- Registration Number
- NCT06362551
- Lead Sponsor
- Inception Fertility Research Institute, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
- All oocyte donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inception Fertility LLC
🇺🇸Houston, Texas, United States