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NCT06373237 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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