Oocyte Donor Application Discrepancies

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06362551
• Other study ID #: INC-GS-2024-002
• Status: Active, not recruiting
• Start date: March 25, 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Inception Fertility, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Inception Fertility LLC	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Inception Fertility, LLC	GeneScreen Counseling, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of additional information	Simple statistical calculations will be evaluated for rate of additional information identified.	6 months
Primary	Rate of applicant decline	Simple statistical calculations will be evaluated for rate of applicant decline based on new information.	6 months