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Cell-free DNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for Preimplantation Genetic Diagnosis

NCT07076719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-07-22

No results posted yet for this study

Summary

This study aims to evaluate the feasibility and accuracy of using cfDNA analysis of spent embryo culture media as a non-invasive approach for PGD. Specifically, the objectives of the study are:

1. To collect SCM from blastocysts of good quality obtained from IVF cycles.
2. To extract cfDNA from the collected SCM using a commercially available kit.
3. To assess the chromosomal content in both cfDNA and gDNA samples via array-based comparative genomic hybridization (aCGH).
4. To compare the results obtained using cfDNA analysis to those obtained using conventional invasive PGD methods, such as blastomere biopsy.
5. To evaluate the potential advantages of using cfDNA analysis of spent embryo culture media for PGD, including reduced risk of harm to the embryo, reduced cost, and increased efficiency.

Conditions

  • to Evaluate the Feasibility and Accuracy of Using cfDNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for PGD

Interventions

DIAGNOSTIC_TEST

Trophectoderm (TE) Biopsy

* Blastocyst Grading: Blastocyst grading was based on criteria that classified embryos as good, fair, or poor using the simplified SART embryo scoring system (Heitmann et al., 2013): * Good: AA or AB. * Fair: BA, BB, BC. * Poor: CB or CC. * Biopsy Criteria: TE biopsy was performed when an embryo had at least one grade B or better for either the ICM or TE on day 5 of development. When no good-quality blastocysts were available in the same cohort, CC grade blastocysts were biopsied. * Biopsy Procedure: 5-8 cells were laser-biopsied from the TE. These cells were then rinsed and tubed for PGT. * Cryopreservation: The biopsied embryo was cryopreserved by vitrification (Ref. 90133, Vit Kit-Freeze, Irvine Scientific, Santa Ana, USA) (Richardson et al., 2015).

DIAGNOSTIC_TEST

Non-invasive Preimplantation Genetic Diagnosis

* DNA Contamination Minimization: o SCM was harvested after embryo culture with care taken not to include cellular material. * Sample Storage: * Processing for Genetic Analysis: 6\. DNA Extraction and Sample Preparation 7. Microarray Comparative Genomic Hybridization (aCGH) * Chromosomal Assessment: * BAC-chip Slides: * Labeling and Hybridization: * Scanning and Data Acquisition: * Data Processing and Analysis: 8\. Validation and Quality Control * Robust quality control measures included:

Sponsors & Collaborators

  • Assisted Reproductive Technology Unit Life Zena Center, Baghdad, Baghdad Governorate, Iraq

    collaborator UNKNOWN

  • Sohag University

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-08-28
Completion
2024-08-28

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076719 on ClinicalTrials.gov