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OpenTrials
Completed

NCT Number: NCT06362551

Oocyte Donor Application Discrepancies

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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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Inception Fertility LLC

Houston, Texas, 77081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of additional information

    Time frame: 6 months

    Simple statistical calculations will be evaluated for rate of additional information identified.

  2. Rate of applicant decline

    Time frame: 6 months

    Simple statistical calculations will be evaluated for rate of applicant decline based on new information.

Sponsors and collaborators

Lead sponsor

Inception Fertility Research Institute, LLC

Industry

Collaborators

  • GeneScreen Counseling, LLC

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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