Non-Euploid Embryo Transfer (NEET) Registry | NCT07036536

Studies
Non-Euploid Embryo Transfer (NEET) Registry

NCT07036536

Sponsor

Inception Fertility Research Institute, LLC

Status

Recruiting

Last Update Posted

Jun 25, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Infertility
Mosaicism
Aneuploidy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2024Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Oct 2, 2024

First Submission Date that Met QC Criteria

Jun 24, 2025

First Posted Date

Jun 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2025

Last Update Posted Date

Jun 25, 2025Actual

Name	Class
CooperSurgical Inc.	INDUSTRY
Igenomix	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The NEET Registry is a registry to track and study the outcomes of non-euploid embryo transfers (NEET) in The Prelude Network

Detailed Description

Preimplantation Genetic Testing for Aneuploidy (PGT-A) is widely offered as an option for patients pursuing pregnancy through in vitro fertilization (IVF). Most often, embryos with normal chromosome results are selected for transfer, with well established outcomes. However, for patient specific reasons, transferring an embryo with a non-euploid result (i.e. mosaic, isolated segmental aneuploid or aneuploidy of whole chromosome(s)) may be considered. Very little information is available on the long-term outcomes of mosaic embryo transfer. Even less has been published on outcomes for other types of non-euploid results. This study aims to collect prenatal, neonatal and pediatric outcome information for embryos transferred with the various types of non-euploid PGT-A results to better inform providers and patients in their decision making regarding such transfers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Embryo Implantation	The frequency of positive pregnancy test (blood serum QHCG) 10-14 days post embryo transfer	5 years

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Rate of Ongoing Pregnancy	The frequency of fetal heart tone identified on ultrasound post embryo transfer around 10-12 weeks gestation	5 years
Rate of Live Birth	The frequency of live birth post embryo transfer

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is planning a non-euploid embryo transfer (NEET) at a fertility clinic in The Prelude Network.
Patient has signed informed consent to participate in the registry.

Exclusion Criteria:

Not applicable

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients planning a non-euploid embryo transfer (NEET) at a fertility clinic in The Prelude Network.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amber Mendoza	Contact	346-393-2265		amendoza@inceptionllc.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inception Fertility Research Institute	Recruiting	Houston	Texas	77081	United States

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D000782	Aneuploidy

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D002869	Chromosome Aberrations
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided