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

Completed

• Conditions: Infertility

• Registration Number: NCT06373237
• Lead Sponsor: Inception Fertility Research Institute, LLC

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.

Study Timeline

• Study Start: 2024-03-26
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-18
• Primary Completion: 2025-04-28
• Study Completion: 2025-04-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Inception Fertility LLC; 🇺🇸 Houston, Texas, United States