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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of additional information
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All oocyte donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.
排除标准
- •Not applicable
结局指标
主要结局
Rate of additional information
时间窗: 6 months
Simple statistical calculations will be evaluated for rate of additional information identified.
Rate of applicant decline
时间窗: 6 months
Simple statistical calculations will be evaluated for rate of applicant decline based on new information.
次要结局
未报告次要终点
