NCT06362551

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

April 8, 2024

Last Update Submit

August 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of additional information

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

    6 months

  • Rate of applicant decline

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

    6 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oocyte donors

You may qualify if:

  • All oocyte donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inception Fertility LLC

Houston, Texas, 77081, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 12, 2024

Study Start

March 25, 2024

Primary Completion

April 24, 2024

Study Completion

April 24, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Locations