Infertility (IVF Patients)NCT07700602
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
An observational study of Infertility (IVF Patients) and Clinical Pregnancy After Single Embryo Transfer, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility (IVF Patients), Clinical Pregnancy After Single Embryo Transfer, Embryo Diagnosis and Selection
- How many people
- 200 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2026to 31 Dec 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
My Duc Hospital
Ho Chi Minh City, 70000
Ha TT Nguyen, MSc, 0933091130, thaiha.nt@myduchospital.vn
About this study
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.
Read the detailed description
Background and Rationale:
Preimplantation genetic testing for aneuploidy (PGT-A) using trophectoderm biopsy has been widely used in IVF to improve embryo selection. However, the invasive nature of embryo biopsy raises concerns about potential impacts on embryo viability and limits its routine use in certain patient populations. Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) has been proposed as an alternative approach that analyzes cell-free DNA (cfDNA) released by the embryo into the spent culture medium (SCM) during in vitro development.
Several studies have demonstrated that cfDNA in SCM can reflect embryonic chromosomal status, but the concordance between NiPGT-A results and trophectoderm biopsy remains variable and influenced by factors such as sampling timing, maternal DNA contamination, embryo mosaicism, and laboratory protocols. Additionally, cases have been reported where embryos classified as aneuploid by NiPGT-A resulted in healthy live births, raising concerns about potential misclassification and highlighting the need for further clinical validation.
Recent research has suggested that NiPGT-A may be more valuable when used as a complementary tool to embryo morphology rather than as a direct replacement for biopsy-based PGT-A. Some studies have also reported that embryos with low or undetectable cfDNA levels in the culture medium may have favorable developmental potential, suggesting that cfDNA characteristics themselves could be associated with embryo viability.
Given the limited clinical evidence, particularly regarding live birth outcomes, further prospective studies are needed to clarify the relationship between NiPGT-A results and reproductive outcomes.
Study Objectives:
The primary objective of this study is to evaluate the correlation between clinical outcomes and NiPGT-A results in patients with favorable prognosis undergoing single blastocyst transfer.
A secondary objective is to explore criteria for embryo selection that combine NiPGT-A results with embryo morphological assessment.
Study Design:
This study is a prospective observational study conducted at My Duc Hospital (Tan Binh and Phu Nhuan centers) in Vietnam. A total of approximately 200 patients with favorable prognosis undergoing IVF/ICSI treatment will be enrolled. Eligible patients are women younger than 35 years with good ovarian response and at least four good-quality embryos on day 3.
Procedures:
Controlled ovarian stimulation will be performed using a standard antagonist protocol. Oocyte retrieval will be followed by intracytoplasmic sperm injection (ICSI), and embryos will be cultured to the blastocyst stage.
On day 5, the best-quality blastocyst (grade 1 or 2) from each patient will be selected. Approximately 10 µL of spent culture medium will be collected for NiPGT-A analysis without performing embryo biopsy. The embryo will then be cryopreserved using vitrification according to standard laboratory procedures.
Cell-free DNA extracted from the spent culture medium will undergo whole genome amplification (WGA) followed by next-generation sequencing to detect chromosomal copy number abnormalities. NiPGT-A results will be categorized into four groups: (1)No result (WGA failure); (2) Euploid; (3) Mosaic; (4) Aneuploid.
Importantly, NiPGT-A results will be blinded to clinicians and patients during the study and will not influence clinical decision-making. Embryo selection for transfer will be based solely on morphological assessment according to routine clinical practice. Frozen embryo transfer will be performed in a hormonally prepared cycle. Pregnancy testing will be conducted 10-14 days after embryo transfer. Ultrasound confirmation of clinical pregnancy will be performed approximately 3 weeks later. Participants will be followed throughout pregnancy and delivery using the hospital clinical database.
Outcome Measures:
Primary Outcome: Ongoing pregnancy or live birth rate after single blastocyst transfer, compared across the four NiPGT-A result groups.
Secondary Outcomes: Positive β-hCG rate, Biochemical pregnancy rate, Clinical pregnancy rate, Miscarriage rate, and prenatal ultrasound findings, including nuchal translucency measurement.
Statistical Analysis:
Continuous variables will be summarized using mean ± standard deviation or median with interquartile range. Categorical variables will be presented as percentages. Comparisons between groups will be performed using chi-square tests or Fisher's exact tests where appropriate. Statistical significance will be defined as p < 0.05. Data analysis will be conducted using R software (version 4.3.0).
Ethical Considerations:
The study uses spent embryo culture medium that would otherwise be discarded during routine IVF laboratory procedures. Collection of the medium does not involve embryo biopsy and does not interfere with embryo development, cryopreservation, or embryo transfer procedures.
Participation in the study does not alter standard clinical care, and NiPGT-A results are not used for clinical decision-making. All participants will provide written informed consent, and patient confidentiality will be strictly maintained.
- Conditions
- Infertility (IVF Patients), Clinical Pregnancy After Single Embryo Transfer, Embryo Diagnosis and Selection
- Keywords
- NiPGT, IVF, morphology, embryo selection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (3)
Positive Beta-hCG Rate by NiPGT-A Result Groups
Defined as serum human chorionic gonadotropin level greater than 25 mIU/mL
Measured: At 2 weeks after embryo placement
Clinical Pregnancy Rate by NiPGT-A Result Groups
Having at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heartbeat activity
Measured: At 7 weeks' gestation
Miscarriage Rate by NiPGT-A Result Groups
The spontaneous loss of an intra-uterine pregnancy prior to or at 20 completed weeks of gestational age
Measured: At 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- My Duc Phu Nhuan Hospital HCMC, Vietnam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700602
- Sponsor's protocol ID
- 01/26/DD-BVMD
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding participant confidentiality and the sensitive nature of reproductive health data. Although all data collected in the study will be de-identified, institutional and ethical regulations restrict public access to individual-level clinical data. Aggregated results will be reported in scientific publications and presentations.
Publications
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.
PubMed 40544577Chen 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.
PubMed 35537927Cheng 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.
PubMed 37500277Kakourou 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.
PubMed 36778192Rubio 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.
PubMed 33741125Sousa 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.
PubMed 35238503Nguyen 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.
PubMed 40399710Vera-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.
PubMed 29471395Rubio 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.
PubMed 32470458Rubio 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.
PubMed 31200971Voros 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.
PubMed 40868262Huang 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.
PubMed 36952146Franco 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.
PubMed 32902935
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07700602
- Acronym / sponsor ID
- 01/26/DD-BVMD
- Conditions
- Infertility (IVF Patients), Clinical Pregnancy After Single Embryo Transfer, Embryo Diagnosis and Selection
- Keywords
- NiPGT, IVF, morphology, embryo selection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Collaborators
- My Duc Phu Nhuan Hospital HCMC, Vietnam
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Preimplantation genetic testing for aneuploidy (PGT-A) using trophectoderm biopsy has been widely used in IVF to improve embryo selection. However, the invasive nature of embryo biopsy raises concerns about potential impacts on embryo viability and limits its routine use in certain patient populations. Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) has been proposed as an alternative approach that analyzes cell-free DNA (cfDNA) released by the embryo into the spent culture medium (SCM) during in vitro development.
Several studies have demonstrated that cfDNA in SCM can reflect embryonic chromosomal status, but the concordance between NiPGT-A results and trophectoderm biopsy remains variable and influenced by factors such as sampling timing, maternal DNA contamination, embryo mosaicism, and laboratory protocols. Additionally, cases have been reported where embryos classified as aneuploid by NiPGT-A resulted in healthy live births, raising concerns about potential misclassification and highlighting the need for further clinical validation.
Recent research has suggested that NiPGT-A may be more valuable when used as a complementary tool to embryo morphology rather than as a direct replacement for biopsy-based PGT-A. Some studies have also reported that embryos with low or undetectable cfDNA levels in the culture medium may have favorable developmental potential, suggesting that cfDNA characteristics themselves could be associated with embryo viability.
Given the limited clinical evidence, particularly regarding live birth outcomes, further prospective studies are needed to clarify the relationship between NiPGT-A results and reproductive outcomes.
Study Objectives:
The primary objective of this study is to evaluate the correlation between clinical outcomes and NiPGT-A results in patients with favorable prognosis undergoing single blastocyst transfer.
A secondary objective is to explore criteria for embryo selection that combine NiPGT-A results with embryo morphological assessment.
Study Design:
This study is a prospective observational study conducted at My Duc Hospital (Tan Binh and Phu Nhuan centers) in Vietnam. A total of approximately 200 patients with favorable prognosis undergoing IVF/ICSI treatment will be enrolled. Eligible patients are women younger than 35 years with good ovarian response and at least four good-quality embryos on day 3.
Procedures:
Controlled ovarian stimulation will be performed using a standard antagonist protocol. Oocyte retrieval will be followed by intracytoplasmic sperm injection (ICSI), and embryos will be cultured to the blastocyst stage.
On day 5, the best-quality blastocyst (grade 1 or 2) from each patient will be selected. Approximately 10 µL of spent culture medium will be collected for NiPGT-A analysis without performing embryo biopsy. The embryo will then be cryopreserved using vitrification according to standard laboratory procedures.
Cell-free DNA extracted from the spent culture medium will undergo whole genome amplification (WGA) followed by next-generation sequencing to detect chromosomal copy number abnormalities. NiPGT-A results will be categorized into four groups: (1)No result (WGA failure); (2) Euploid; (3) Mosaic; (4) Aneuploid.
Importantly, NiPGT-A results will be blinded to clinicians and patients during the study and will not influence clinical decision-making. Embryo selection for transfer will be based solely on morphological assessment according to routine clinical practice. Frozen embryo transfer will be performed in a hormonally prepared cycle. Pregnancy testing will be conducted 10-14 days after embryo transfer. Ultrasound confirmation of clinical pregnancy will be performed approximately 3 weeks later. Participants will be followed throughout pregnancy and delivery using the hospital clinical database.
Outcome Measures:
Primary Outcome: Ongoing pregnancy or live birth rate after single blastocyst transfer, compared across the four NiPGT-A result groups.
Secondary Outcomes: Positive β-hCG rate, Biochemical pregnancy rate, Clinical pregnancy rate, Miscarriage rate, and prenatal ultrasound findings, including nuchal translucency measurement.
Statistical Analysis:
Continuous variables will be summarized using mean ± standard deviation or median with interquartile range. Categorical variables will be presented as percentages. Comparisons between groups will be performed using chi-square tests or Fisher's exact tests where appropriate. Statistical significance will be defined as p < 0.05. Data analysis will be conducted using R software (version 4.3.0).
Ethical Considerations:
The study uses spent embryo culture medium that would otherwise be discarded during routine IVF laboratory procedures. Collection of the medium does not involve embryo biopsy and does not interfere with embryo development, cryopreservation, or embryo transfer procedures.
Participation in the study does not alter standard clinical care, and NiPGT-A results are not used for clinical decision-making. All participants will provide written informed consent, and patient confidentiality will be strictly maintained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ongoing Pregnancy/Live Birth Rate by NiPGT-A Result Groups
Time frame: Up to 12 weeks
Presence of at least one intrauterine gestational sac with fetal cardiac activity confirmed by ultrasound at 12 weeks' gestation.
3 secondary outcomes
Positive Beta-hCG Rate by NiPGT-A Result Groups
Time frame: At 2 weeks after embryo placement
Clinical Pregnancy Rate by NiPGT-A Result Groups
Time frame: At 7 weeks' gestation
Miscarriage Rate by NiPGT-A Result Groups
Time frame: At 20 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 40544577Huang 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.
- Results publication: PubMed 35537927Chen 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.
- Results publication: PubMed 37500277Cheng 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.
- Results publication: PubMed 36778192Kakourou 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.
- Results publication: PubMed 33741125Rubio 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.
- Results publication: PubMed 35238503Sousa 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.
- Results publication: PubMed 40399710Nguyen 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.
- Results publication: PubMed 29471395Vera-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.
- Results publication: PubMed 32470458Rubio 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.
- Results publication: PubMed 31200971Rubio 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.
- Results publication: PubMed 40868262Voros 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.
- Results publication: PubMed 36952146Huang 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding participant confidentiality and the sensitive nature of reproductive health data. Although all data collected in the study will be de-identified, institutional and ethical regulations restrict public access to individual-level clinical data. Aggregated results will be reported in scientific publications and presentations.
Related trials for Infertility (IVF Patients)
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Recruiting
The Effects of Carnitine Supplementation on Oocytes in Women Undergoing IVF Process
Infertility (IVF Patients)
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility (IVF Patients) and Clinical Pregnancy After Single Embryo Transfer, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HA TT NGUYEN, MSc (+84933091130, thaiha.nt@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy/Live Birth Rate by NiPGT-A Result Groups (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07700602, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.