Inception Fertility LLC
Houston, Texas, 77081, United States
NCT Number: NCT06362551
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.
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Observational
Houston, Texas, 77081, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Simple statistical calculations will be evaluated for rate of additional information identified.
Time frame: 6 months
Simple statistical calculations will be evaluated for rate of applicant decline based on new information.
Inception Fertility Research Institute, LLC
Industry
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
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