Correlation Of Clinical Outcomes After Transfer Of Good-Quality Morphology Embryos In Patients With A Favorable Prognosis And Non-Invasive Preimplantation Genetic Testing For Aneuploidy (NiPGT-A) Results

NCT07700602 | Not Yet Recruiting DMC

• 1 other identifier: 01/26/DD-BVMD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) is an emerging approach that analyzes embryonic cell-free DNA (cfDNA) released into the spent culture medium (SCM) to assess chromosomal status without performing trophectoderm biopsy. This technique has the potential to reduce procedural invasiveness and eliminate biopsy-related risks while providing additional information for embryo selection in assisted reproductive technology (ART). However, the clinical value of NiPGT-A remains uncertain because available evidence is limited and largely derived from observational studies, with few studies reporting live birth outcomes. This prospective observational study aims to evaluate the correlation between NiPGT-A results and clinical outcomes after single blastocyst transfer in patients with a favorable prognosis undergoing IVF/ICSI treatment. In this study, embryos with good morphological quality will undergo non-invasive sampling of spent culture medium for cfDNA analysis. NiPGT-A results will be categorized into four groups: no result, euploid, mosaic, and aneuploid. The study will compare pregnancy and birth outcomes across these groups to determine the clinical utility of NiPGT-A in embryo selection strategies.

Conditions

Infertility (IVF Patients); Clinical Pregnancy After Single Embryo Transfer; Embryo Diagnosis and Selection

Keywords

NiPGT, IVF, morphology, embryo selection

Outcome Measures

Primary Outcomes (1)

• Ongoing Pregnancy/Live Birth Rate by NiPGT-A Result Groups

  Presence of at least one intrauterine gestational sac with fetal cardiac activity confirmed by ultrasound at 12 weeks' gestation.

  Up to 12 weeks

Secondary Outcomes (3)

• Positive Beta-hCG Rate by NiPGT-A Result Groups

  At 2 weeks after embryo placement

• Clinical Pregnancy Rate by NiPGT-A Result Groups

  At 7 weeks' gestation

• Miscarriage Rate by NiPGT-A Result Groups

  At 20 weeks of gestation

Study Arms (4)

No Result (WGA Failure) NiPGT -A

Embryos classified as having no NiPGT-A result due to unsuccessful whole genome amplification (WGA) of cell-free DNA obtained from the spent culture medium. These embryos are selected for transfer based solely on morphological assessment. Clinical outcomes after single frozen embryo transfer will be evaluated in this group.

Euploid NiPGT-A

Embryos classified as euploid based on NiPGT-A analysis of cell-free DNA obtained from the spent culture medium. Embryo selection for transfer is based only on morphological criteria according to routine clinical practice, and NiPGT-A results are blinded during treatment. Clinical outcomes will be compared with other NiPGT-A result groups.

Mosaic NiPGT-A

Embryos classified as mosaic according to NiPGT-A analysis of cell-free DNA from the spent culture medium. As in other groups, embryo transfer decisions are based solely on morphological evaluation, and NiPGT-A results are not used for clinical decision-making during the study.

Aneuploid NiPGT-A

Embryos classified as aneuploid according to NiPGT-A analysis of cell-free DNA obtained from the spent culture medium. Embryos included in this cohort are transferred based on morphological assessment without knowledge of NiPGT-A results. Clinical outcomes will be analyzed and compared with other groups.

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women with good reproductive prognosis undergoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) at My Duc Tan Binh Hospital and My Duc Phu Nhuan Hospital. Eligible participants are women aged 18 to 34 years with normal ovarian response, undergoing their first or second IVF cycle, and having at least one morphologically good-quality blastocyst available for frozen single embryo transfer. All participants receive standard IVF treatment according to routine clinical practice. Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) is performed retrospectively using spent embryo culture media collected prior to embryo cryopreservation and is not used for clinical decision-making during the study.

You may qualify if:

• Women undergoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI).
• Age younger than 35 years at the time of oocyte retrieval.
• Good ovarian response, defined as having at least four good-quality embryos (Grade 1 or Grade 2) on Day 3 or later.
• Undergoing the first or second IVF cycle.
• Normal semen parameters of the male partner.
• Willing to undergo non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using spent embryo culture media.
• Agree to vitrification of a single morphologically best-quality blastocyst and to undergo frozen single embryo transfer.
• Able and willing to provide written informed consent.

You may not qualify if:

• Presence of untreated uterine abnormalities, including uterine malformations or significant intrauterine pathology.
• History of uterine surgery.
• History of ovarian surgery.
• Known metabolic disorders.
• Use of donor oocytes.
• In vitro maturation (IVM) cycles.
• Participation in another clinical study during the study period.
• Patients who do not undergo frozen single embryo transfer.

Sponsors & Collaborators

• Mỹ Đức Hospital: lead
• My Duc Phu Nhuan Hospital HCMC, Vietnam: collaborator

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (13)

• Huang J, Yao Y, Jia J, Wang Z, Shi X, Li Y, Wang Y, Li R, Qiao J, Ma S, Huang L, Wang J, Liu P, Lu S, Qiao J. Library concentration of cell-free DNA in spent culture medium: a potential indicator for clinical outcomes of blastocyst transfer. Reprod Biomed Online. 2025 Aug;51(2):104752. doi: 10.1016/j.rbmo.2024.104752. Epub 2024 Dec 18.

  PMID: 40544577 RESULT

• Chen L, Li W, Liu Y, Peng Z, Cai L, Zhang N, Xu J, Wang L, Teng X, Yao Y, Zou Y, Ma M, Liu J, Lu S, Sun H, Yao B. Non-invasive embryo selection strategy for clinical IVF to avoid wastage of potentially competent embryos. Reprod Biomed Online. 2022 Jul;45(1):26-34. doi: 10.1016/j.rbmo.2022.03.006. Epub 2022 Mar 11.

  PMID: 35537927 RESULT

• Cheng HYH, Chow JFC, Lam KKW, Lai SF, Yeung WSB, Ng EHY. Randomised double-blind controlled trial of non-invasive preimplantation genetic testing for aneuploidy in in vitro fertilisation: a protocol paper. BMJ Open. 2023 Jul 27;13(7):e072557. doi: 10.1136/bmjopen-2023-072557.

  PMID: 37500277 RESULT

• Kakourou G, Mamas T, Vrettou C, Traeger-Synodinos J. An Update on Non-invasive Approaches for Genetic Testing of the Preimplantation Embryo. Curr Genomics. 2022 Nov 18;23(5):337-352. doi: 10.2174/1389202923666220927111158.

  PMID: 36778192 RESULT

• Rubio C, Racowsky C, Barad DH, Scott RT Jr, Simon C. Noninvasive preimplantation genetic testing for aneuploidy in spent culture medium as a substitute for trophectoderm biopsy. Fertil Steril. 2021 Apr;115(4):841-849. doi: 10.1016/j.fertnstert.2021.02.045. Epub 2021 Mar 17. No abstract available.

  PMID: 33741125 RESULT

• Sousa LN, Monteiro PB. Non-invasive preimplantation genetic testing: a literature review. JBRA Assist Reprod. 2022 Aug 4;26(3):554-558. doi: 10.5935/1518-0557.20210102.

  PMID: 35238503 RESULT

• Nguyen HTT, Luu TTM, Do LT, Nguyen TC, Nguyen DTN, Ho TTM, Giang H, Dao TTH, Huynh BG, Ho TM, Vuong LN. Non-invasive preimplantation genetic testing for aneuploidy using cell-free DNA in blastocyst culture medium. J Assist Reprod Genet. 2025 Aug;42(8):2587-2595. doi: 10.1007/s10815-025-03510-9. Epub 2025 May 21.

  PMID: 40399710 RESULT

• Vera-Rodriguez M, Diez-Juan A, Jimenez-Almazan J, Martinez S, Navarro R, Peinado V, Mercader A, Meseguer M, Blesa D, Moreno I, Valbuena D, Rubio C, Simon C. Origin and composition of cell-free DNA in spent medium from human embryo culture during preimplantation development. Hum Reprod. 2018 Apr 1;33(4):745-756. doi: 10.1093/humrep/dey028.

  PMID: 29471395 RESULT

• Rubio 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 RESULT

• Rubio 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 RESULT

• Voros C, Darlas M, Athanasiou D, Athanasiou A, Athanasiou A, Bananis K, Papadimas G, Tsimpoukelis C, Gkirgkinoudis A, Sapantzoglou I, Papapanagiotou I, Vaitsis D, Koulakmanidis AM, Topalis V, Thomakos N, Theodora M, Antsaklis P, Chatzinikolaou F, Dahl HA, Daskalakis G, Loutradis D. Evaluation of the Effectiveness and Accuracy of Non-Invasive Preimplantation Genetic Testing (niPGT) Compared to Invasive Embryo Biopsy. Biomedicines. 2025 Aug 18;13(8):2010. doi: 10.3390/biomedicines13082010.

  PMID: 40868262 RESULT

• Huang B, Luo X, Wu R, Qiu L, Lin S, Huang X, Wu J. Evaluation of non-invasive gene detection in preimplantation embryos: a systematic review and meta-analysis. J Assist Reprod Genet. 2023 Jun;40(6):1243-1253. doi: 10.1007/s10815-023-02760-9. Epub 2023 Mar 23.

  PMID: 36952146 RESULT

• Franco JG Jr, Dieamant F, Oliveira JBA. Noninvasive preimplantation genetic testing for aneuploidies (niPGT-A) and the principle of primum non nocere. JBRA Assist Reprod. 2020 Oct 6;24(4):391-393. doi: 10.5935/1518-0557.20200075.

  PMID: 32902935 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Spent embryo culture medium is collected on Day 5 of embryo development prior to blastocyst cryopreservation. The culture medium, which would otherwise be discarded during routine IVF laboratory procedures, is collected without any manipulation, biopsy, or disturbance of the embryo. These samples contain embryonic cell-free DNA and are used for non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) for research purposes. All samples are coded and de-identified prior to genetic analysis to protect participant confidentiality. No additional biological samples are collected from participants beyond routine clinical procedures, and the results of sample analysis are not used to guide clinical decision-making during the study.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

HA TT NGUYEN, MSc

CONTACT

+84933091130; thaiha.nt@myduchospital.vn

TAM TM LUU, MSc

CONTACT

+84 357 426 024; tam.ltm@myduchospital.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)