Outcome of Embryos Transferred After Initial Chaotic Resu... | NCT06373237

Studies
Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A

NCT06373237

Sponsor

Inception Fertility Research Institute, LLC

Status

Completed

Last Update Posted

Jul 20, 2025Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Infertility

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2024Actual

Primary Completion Date

Apr 28, 2025Actual

Completion Date

Apr 28, 2025Actual

First Submitted Date

Apr 8, 2024

First Submission Date that Met QC Criteria

Apr 17, 2024

First Posted Date

Apr 18, 2024Actual

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

Jul 16, 2025

Last Update Posted Date

Jul 20, 2025Actual

Name	Class
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

This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed.

Detailed Description

Primary objective: to observe the outcomes of embryos transferred with initial "chaotic" results on PGT-A via Igenomix.

Hypothesis: The transfer of chaotic embryos can result in clinical pregnancy, as defined by fetal heartbeat at 6-8 weeks gestation. Furthermore, these transfers may also result in live birth and expand reproductive potential for patients seeking IVF with PGT-A.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Embryo re-biopsy rate	Frequency of re-biopsy post initial chaotic PGT-A result	2 years
Embryo transfer rate	Frequency of embryo transfer post re-biopsy	2 years
Pregnancy rate	Frequency of positive serum pregnancy test post embryo transfer of initial chaotic embryo	2 years
Live birth rate	Frequency of live birth post embryo transfer of initial chaotic embryo	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients that conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.

Exclusion Criteria:

Patients who had multiple embryo transfer.

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

Women of any age who have conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inception Fertility LLC		Houston	Texas	77081	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided