An interventional study of Non-invasive chromosome screening（NICS） in Infertility and Chromosome Abnormality, sponsored by Peking University Third Hospital. Completed at 13 sites in China. Open to female participants aged 35 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Screening
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.
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
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 1,152 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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Exclusion Criteria:
Single thawed blastocyst transfer with blastocyst selection according to the analysis of NICS and morphologic score.
Diagnostic Test: Non-invasive chromosome screening（NICS）
Single thawed blastocyst transfer with blastocyst selection according to morphologic score.
NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium
Ongoing pregnancy rate
Number of women with ongoing pregnancies after the first transfer/ number of women randomized to the specific group
Time frame: 12 weeks after the first embryo transfer
Clinical pregnancy rate
Number of women with clinical pregnancies after the first transfer / number of women randomized to the specific group
Time frame: 7 weeks after the first embryo transfer
Miscarriage rate
Number of pregnancy losses / number of clinical pregnancies after the first transfer.
Time frame: Miscarriage：28 weeks of after the first embryo transfer； First trimester miscarriage(early miscarriage)：12 weeks of after the first embryo transfer；
Live birth rate
Number of women with live births after the first transfer / number of women randomized to the specific group.
Time frame: within 2 weeks after live birth
Plan to share: Yes — Data may be shared with proper internal and ethical approval. De-identified data may also be shared with approved study investigators.
Supporting information: Study protocol
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital