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Trial · Observational

CompletedPhase not statedRegistry data

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

NCTNCT07076719 (opens ClinicalTrials.gov in a new tab)Other idCSRE-16-24
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
20 participants (actual)
Sponsor
Sohag University · Other
Design
Not stated
Countries
1 country

Iraq

Start
1 Oct 2023
Primary completion
28 Aug 2024
Completion
28 Aug 2024
First posted
22 Jul 2025
Last update posted
22 Jul 2025
Conditions
to Evaluate the Feasibility and Accuracy of Using cfDNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for PGD

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph –

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

    NCT07076719

    1 Oct 2023 to 28 Aug 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Trophectoderm (TE) BiopsyDiagnostic test
  • Non-invasive Preimplantation Genetic DiagnosisDiagnostic test

Arms1

  • Other

    Group 1

    Patients underwent controlled ovarian stimulation using either: o A long down-regulation protocol with buserelin nasal spray (Suprecur, Hoechst, Germany). A short protocol incorporating a gonadotropin-releasing hormone (GnRH) antagonist. * Gonadotropin Administration: Daily administration included highly purified human menopausal gonadotropin or recombinant FSH. Doses ranged from 150 to 450 IU. * Ovulation Trigger: Ovulation was triggered when at least three follicles reached ≥18 mm in diameter. The trigger agents used were either 5,000 IU of hCG or 0.2 mg triptorelin). * Oocyte Retrieval: Transvaginal oocyte retrieval was performed 36 hours post-trigger, followed by intracytoplasmic sperm injection (ICSI). 3\. Fertilization and Embryo Culture 4. Trophectoderm (TE) Biopsy 5. Sample Collection and Processing

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Diagnostic accuracy

    Time frame · 12 moponths

    Registry description

    Accuracy of using cfDNA analysis of spent embryo culture media as a non-invasive approach for PGD in comparison to traditional trophectoderm biopsy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

7 results

Can pregnancy rate be improved in gonadotropin-releasing hormone (GnRH) antagonist cycles by administering GnRH agonist before oocyte retrieval? A prospective, randomized study.

Schachter et al. 2008Fertility and sterilitycited by 73

PMID 18023439DOI 10.1016/j.fertnstert.2007.07.1316PUB-18023439

Full text at the publisher7 results
Publisher pageSee results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultRubio C, Rienzi L, Navarro-Sanchez L, Cimadomo D, Garcia-Pascual CM, Albricci L, Soscia D, Valbuena D, Capalbo A, Ubaldi F, Simon C. Embryonic cell-free DNA versus trophectoderm biopsy for aneuploidy testing: concordance rate and clinical implications. Fertil Steril. 2019 Sep;112(3):510-519. doi: 10.1016/j.fertnstert.2019.04.038. Epub 2019 Jun 11. PMID 31200971
  • ResultYatsenko SA, Shaw CA, Ou Z, Pursley AN, Patel A, Bi W, Cheung SW, Lupski JR, Chinault AC, Beaudet AL. Microarray-based comparative genomic hybridization using sex-matched reference DNA provides greater sensitivity for detection of sex chromosome imbalances than array-comparative genomic hybridization with sex-mismatched reference DNA. J Mol Diagn. 2009 May;11(3):226-37. doi: 10.2353/jmoldx.2009.080064. Epub 2009 Mar 26. PMID 19324990
  • ResultMertzanidou A, Wilton L, Cheng J, Spits C, Vanneste E, Moreau Y, Vermeesch JR, Sermon K. Microarray analysis reveals abnormal chromosomal complements in over 70% of 14 normally developing human embryos. Hum Reprod. 2013 Jan;28(1):256-64. doi: 10.1093/humrep/des362. Epub 2012 Oct 9. PMID 23054067
  • ResultRubio C, Navarro-Sanchez L, Garcia-Pascual CM, Ocali O, Cimadomo D, Venier W, Barroso G, Kopcow L, Bahceci M, Kulmann MIR, Lopez L, De la Fuente E, Navarro R, Valbuena D, Sakkas D, Rienzi L, Simon C. Multicenter prospective study of concordance between embryonic cell-free DNA and trophectoderm biopsies from 1301 human blastocysts. Am J Obstet Gynecol. 2020 Nov;223(5):751.e1-751.e13. doi: 10.1016/j.ajog.2020.04.035. Epub 2020 May 26. PMID 32470458
  • ResultMagli MC, Van den Abbeel E, Lundin K, Royere D, Van der Elst J, Gianaroli L; Committee of the Special Interest Group on Embryology. Revised guidelines for good practice in IVF laboratories. Hum Reprod. 2008 Jun;23(6):1253-62. doi: 10.1093/humrep/den068. Epub 2008 Mar 28. PMID 18375408
  • ResultKrasic J, Abramovic I, Vrtaric A, Nikolac Gabaj N, Kralik-Oguic S, Katusic Bojanac A, Jezek D, Sincic N. Impact of Preanalytical and Analytical Methods on Cell-Free DNA Diagnostics. Front Cell Dev Biol. 2021 Sep 6;9:686149. doi: 10.3389/fcell.2021.686149. eCollection 2021. PMID 34552921
  • ResultZeng W, Xiao D, Chen R, Lu Y, Liang W, Sun H. A novel method for gas mixing and distribution in multi-chamber embryo incubators. Technol Health Care. 2024;32(S1):169-181. doi: 10.3233/THC-248015. PMID 38759047
  • ResultBosch E, Alama P, Romero JL, Mari M, Labarta E, Pellicer A. Serum progesterone is lower in ovarian stimulation with highly purified HMG compared to recombinant FSH owing to a different regulation of follicular steroidogenesis: a randomized controlled trial. Hum Reprod. 2024 Feb 1;39(2):393-402. doi: 10.1093/humrep/dead251. PMID 38037188
  • ResultRavhon A, Aurell R, Lawrie H, Margara R, Winston RM. The significance of delayed suppression using buserelin acetate and recombinant follicle-stimulating hormone in a long protocol in vitro fertilization program. Fertil Steril. 2000 Feb;73(2):325-9. doi: 10.1016/s0015-0282(99)00521-x. PMID 10685537
  • ResultYu, Y., Liang, X., Wang, W., et al. (2017). Whole-genome sequencing reveals multiple genetic alterations in mesonephric-like adenocarcinomas of the female genital tract. Gynecologic Oncology, 147(3), 617-625.
  • ResultXiong, B., Ma, H., Zhang, F., Li, Y., Zhou, C., Huang, L., Zhang, Y., Li, R., Wei, J., Liu, P., Wang, J., Tang, F., Liu, Z., Gao, F., & Li, J. (2012). A comparison of human embryo genome-wide copy number profiles was obtained using two different microarray platforms. Reproductive BioMedicine Online, 25(2), 155-161.
  • ResultWong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3. PMID 20890283
  • ResultWang, Y., Cheng, Q., Meng, L., et al. (2017). Non-invasive detection of genome-wide somatic copy number alterations by liquid biopsies in patients with hepatocellular carcinoma. Oncotarget, 8(33), 54707.
  • ResultWang, Y., Chen, Y., Zhang, J., Liang, X., Xu, J., Wang, W., Zhang, X., Li, J., Jin, L., & Li, Z. (2018). Whole-genome sequencing of human preimplantation embryos reveals genetic abnormalities and embryonic development. Cell Research, 28(10), 973-987.
  • ResultWang, L., Zhang, J., Duan, J., et al. (2019). Assessment of human embryos by RNA sequencing, whole-exome sequencing, and karyomapping. Molecular Genetics & Genomic Medicine, 7(7), e00715.
  • ResultVerlinsky, Y., Rechitsky, S., Verlinsky, O., et al. (2013). Preimplantation genetic diagnosis using polar bodies and blastomeres of cleavage stage embryos. Molecular and Cellular Endocrinology, 15(6), 334-339.
  • ResultVassena R, Boue S, Gonzalez-Roca E, Aran B, Auer H, Veiga A, Izpisua Belmonte JC. Waves of early transcriptional activation and pluripotency program initiation during human preimplantation development. Development. 2011 Sep;138(17):3699-709. doi: 10.1242/dev.064741. Epub 2011 Jul 20. PMID 21775417
  • ResultScott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1. PMID 23731996
  • ResultScott RT Jr, Upham KM, Forman EJ, Zhao T, Treff NR. Cleavage-stage biopsy significantly impairs human embryonic implantation potential while blastocyst biopsy does not: a randomized and paired clinical trial. Fertil Steril. 2013 Sep;100(3):624-30. doi: 10.1016/j.fertnstert.2013.04.039. Epub 2013 Jun 15. PMID 23773313

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: All patients referred for PGT-A. Exclusion Criteria: Patients who had no blastocyst for biopsy were excluded

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