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

Infertility Clinical Trial

Official title:

Retrospective Observation of Outcomes of Embryos Transferred After Initial Chaotic Results on Preimplantation Genetic Testing for Aneuploidy (PGT-A)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06373237
• Other study ID #: INC-IG-2024-001
• Status: Active, not recruiting
• Start date: March 26, 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Inception Fertility, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: May 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Inception Fertility LLC	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Inception Fertility, LLC	Igenomix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of embryo re-biopsy	How many embryos with an initial chaotic result were re-biopsied?	2 years
Primary	Re-biopsy results	If re-biopsy occurred, what was the second biopsy sample PGT lab result?	2 years
Primary	Embryo disposition	If second biopsy result was euploid, was the embryo transferred?	2 years
Primary	Embryo transfer outcome	If the embryo was transferred, did it result in positive serum pregnancy test?	2 years
Primary	Pregnancy outcome	If the transfer resulted in positive serum pregnancy test, what was the pregnancy outcome? (Spontaneous abortion, ectopic, ongoing, live birth)	2 years