AzTrials
AzTrials

InfertilityESNi-PGTNCT04339166

Embryo Selection by Noninvasive Preimplantation Genetic Test

A study testing Non-invasive chromosome screening（NICS） in people with Infertility and Chromosome Abnormality, run by Peking University Third Hospital at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to explore whether non-invasive chromosome screening (NICS) can be used as an effective indicator for embryos selection besides morphology through a multicenter randomized controlled trial, by comparing the differences of live birth rate, pregnancy rate and miscarriage rate between the… Read more about this study

Who is it for?
Ages 35 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Chromosome Abnormality
What is being tested?
Non-invasive chromosome screening（NICS）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,152 participants
Where
13 sitesChina
Study dates
16 Apr 2020to 6 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 42 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle
  • Female age: 35 - 42 years old
  • Women receiving controlled ovarian hyperstimulation treatment (including ultra-long protocol、long-protocol 、short protocol treatment with GnRH agonist and GnRH antagonist treatment protocol); and the number of oocytes ≥6; The female BMI is from 18 to 30kg/m2.
  • Culture embryos to blastocyst stage and all the blastocysts will be single cryopreserved.
  • Single frozen-thawed blastocyst Transferred for the first time
  • The number of blastocysts ≥2, morphology grade (above 4BC/4CB)
  • Written informed consent

Who cannot join

  • One of couples with IVF or ICSI contraindications(such as poorly controlled type I or type II diabetes; liver disease or dysfunction; kidney disease or renal function abnormality; significant anemia; history of deep venous thrombosis, pulmonary embolus; history of cerebrovascular accident; uncontrolled hypertension or diagnosed heart disease; history of cervical, endometrial or breast cancer; undiagnosed vaginal bleeding.)
  • PGT cycles
  • Women who have pathologies or malformations that affect the pregnancy outcome: genital malformations, untreated hydrosalpinx, untreated uterine infections, intramural myomas > 4cm , benign tumor of pelvic and abdominal cavity> 4cm, intimal thickness<8mm, pituitary tumors and malignant tumors of various tissues and organs during the patient's participation in the study
  • Untreated hyperprolactinemia, thyroid disease, adrenal disease
  • Women with endometrial polyps that were not treated before embryo transfer

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Peking University Third Hospital

    Beijing

  • The First Medical Center of Chinese People's Liberation Army General Hospital

    Beijing

  • Reproductive & Genetic Hospital of Citic-Xiangya

    Changsha, Hunan

  • West China Second Hospital of Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital,Sun Yat-sen University

    Guanzhou, Guangdong

  • Jinling Hospital,Nanjing University,School Medicine

    Nanjing, Jiangsu

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Hebei Maternity and Reproductive hospital

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Northwest women's and children's hospital

    Xi'an

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multicenter Clinical Study on Embryo Selection by Using the Ploidy of Cell Free DNA in Embryo Culture Medium

The objective of this study is to explore whether non-invasive chromosome screening (NICS) can be used as an effective indicator for embryos selection besides morphology through a multicenter randomized controlled trial, by comparing the differences of live birth rate, pregnancy rate and miscarriage rate between the two groups of embryo selection by "NICS+ morphology" and embryo selection only by "morphology" in IVF cycle.

Read the detailed description

Chromosomal abnormalities commonly exist in early human embryos, and often cause embryo implantation failure and pregnancy loss in in-vitro fertilization (IVF) treatments. Preimplantation genetic testing for aneuploidies (PGT-A) by comprehensive chromosome screening (CCS) has been widely applied in IVF practices to select embryos with normal ploidy. Although multiple clinical trials have demonstrated improved clinical outcomes with PGT-A, it's in controversial for whether PGT-A is truly worthwhile to be offered to all IVF patients. One of the main concerns is that it involves an embryo biopsy procedure, which is invasive and the long-term safety issue of the embryo biopsy remains to be fully investigated.

In recent years, researchers have found that the spent medium of embryo culture contains trace amount of cell-free DNA, which may reflect the ploidy of the embryo. The non-invasive chromosome screening (NICS) approach utilizing spent culture medium samples has been evaluated in studies. However, the clinical value of NICS as a new effective indicator to evaluate embryo competence so far has not been justified by randomized clinical trials.

The main purpose of this project is to verify whether NICS can be used as a new effective indicator for evaluating embryo developmental potential through multi-center, randomized clinical trials

Being tested
Non-invasive chromosome screening（NICS）
Keywords
Culture media, Embryonic cell-free DNA, Euploidy
Medical subject headings
Infertility, Chromosome Aberrations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive chromosome screening（NICS）Diagnostic test

    NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium

Study groups in NCT04339166
Study groupRoleWhat they receive
Group AExperimentalSingle thawed blastocyst transfer with blastocyst selection according to the analysis of NICS and morphologic score.
Receives: Diagnostic Test: Non-invasive chromosome screening（NICS）
Group BNo interventionSingle thawed blastocyst transfer with blastocyst selection according to morphologic score.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancy rate

    Number of women with ongoing pregnancies after the first transfer/ number of women randomized to the specific group

    Measured: 12 weeks after the first embryo transfer

Secondary outcomes (3)

  1. Clinical pregnancy rate

    Number of women with clinical pregnancies after the first transfer / number of women randomized to the specific group

    Measured: 7 weeks after the first embryo transfer

  2. Miscarriage rate

    Number of pregnancy losses / number of clinical pregnancies after the first transfer.

    Measured: Miscarriage：28 weeks of after the first embryo transfer； First trimester miscarriage(early miscarriage)：12 weeks of after the first embryo transfer；

  3. Live birth rate

    Number of women with live births after the first transfer / number of women randomized to the specific group.

    Measured: within 2 weeks after live birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2020
  2. Study start16 Apr 2020
  3. Primary completion28 Feb 2024
  4. Study completion6 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339166
Sponsor's protocol ID
ESNi-PGT
Acronym
ESNi-PGT
Status last verified
Dec 2025
First submitted
1 Apr 2020
Last updated
11 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data may be shared with proper internal and ethical approval. De-identified data may also be shared with approved study investigators.

Publications

  • Huang J, Li R, Zeng L, Hu L, Cai L, Chen L, Shi J, Wang Y, Guan Y, Xu Y, Qian W, Wang X, Xi H, Zhao Z, Yao Y, Lu S, Yao Y, Wang J, Liu P, Qiao J. Embryo selection by non-invasive preimplantation genetic testing for aneuploidy in women of advanced maternal age: a randomized, clinical trial. Nat Commun. 2026 Sep 8;17(1):10634. doi: 10.1038/s41467-026-77628-4.

    PubMed 42850238

  • Huang J, Rong L, Zeng L, Hu L, Shi J, Cai L, Yao B, Wang XX, Xu Y, Yao Y, Wang Y, Zhao J, Guan Y, Qian W, Hao G, Lu S, Liu P, Qiao J. Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial. BMJ Open. 2022 Jul 27;12(7):e057254. doi: 10.1136/bmjopen-2021-057254.

    PubMed 35896299

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive chromosome screening（NICS） in people with Infertility and Chromosome Abnormality, run by Peking University Third Hospital at 13 sites in China.

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 7 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy rate (time frame: 12 weeks after the first embryo transfer). 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 NCT04339166, which also lists 2 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 11 Dec 2025.

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