Oocyte Donor Application Discrepancies

Status Active, not recruiting

Clinical Trial 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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Infertility

Clinical Trial Details

NCT number	NCT06362551
Study type	Observational
Source	Inception Fertility, LLC
Contact
Status	Active, not recruiting
Phase
Start date	March 25, 2024
Completion date	May 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.