An observational study in Infertility Assisted Reproductive Technology, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Not yet recruiting at 7 sites in 5 countries. Open to female participants aged 20 Years to 46 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Observational
The goals of this international multicenter cross-sectional study are:
The study will enroll patients undergoing PGT-A from seven domestic and international centers, with patient enrollment expected to be completed within one year. PGT-A upgrade testing will be performed on embryos from enrolled patients, and the incidence rates of Incidence of microdeletions/microduplications, heteroploidy, LOH will be statistically analyzed. All patients who undergo embryo transfer will be followed up for clinical outcomes and birth defects.
The study will enroll 6,694 embryos derived from typical fertilization (2PN) that meet the inclusion and exclusion criteria in patients undergoing PGT-A, as well as all embryos derived from atypical fertilization (0PN/1PN/3PN). In contrast to conventional PGT-A testing, PGT-A upgrade testing will be performed on the embryos to comprehensively analyze multiple embryonic abnormalities in a single detection, including aneuploidy, mosaicism, microdeletion/microduplication, heteroploidy, and loss of heterozygosity (LOH), and to calculate their respective incidence rates.
In addition to embryos derived from 2PN, embryos from 0PN/1PN/3PN will also be cultured to the blastocyst stage for trophectoderm (TE) cell biopsy. Euploid embryos identified by PGT-A upgrade testing will be recorded, and the utilization rate of atypically fertilized embryos will be evaluated.
For mosaic embryos, a previously established parental haplotype origin algorithm will be applied to distinguish true versus false mosaicism and identify the origin of abnormalities, thereby recognizing "false-positive" mosaic embryos and further increasing the number of transferable embryos.
Patients will receive euploid embryo transfer (from 2PN) in accordance with routine clinical practice. In cases where no 2PN-derived euploid embryos are available, transfer of 0PN/1PN/3PN-derived euploid embryos and embryos classified as "false-positive" mosaic may be considered after the patient has been fully informed of the risks and provided informed consent.
All transfer cycles will be followed up for prenatal diagnosis results and birth defects. The primary outcome measures are the incidence rates of microdeletion/microduplication, heteroploidy, and LOH. The secondary outcome measures include embryo utilization rate, clinical pregnancy rate, ongoing pregnancy rate, live birth rate, miscarriage rate, concordance rate between prenatal diagnosis results and PGT-A results, and birth defect rate.
The maximum follow-up duration will be 1 year after embryo transfer. Clinical and embryology laboratory procedures during the study will not be altered and will be performed in accordance with each center's routine practice.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
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This study is a cross-sectional study with a two-sided test and α = 0.05. Based on the analysis of existing data from previous PGT-A upgrade studies performed in 2PN embryos, the total incidence rate (p) of microdeletion/microduplication, heteroploidy, and UPD/LOH in euploid embryos is estimated to be 2.0%, with a margin of error (δ) of 0.005. The required number of euploid embryos is 3,012, and the calculation formula is provided below. Given that the euploidy rate is approximately 50%, a total of 6,024 embryos tested by PGT-A upgrade needs to be enrolled. Considering the potential dropout risk (10%), 6,694 embryos from two pronuclei (PN) are included. All embryos from 0PN/1PN/3PN are included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(1) Any one of the following conditions being met is sufficient:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: PGT-A upgrade
A comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and LOH in a single assay.
Incidence of microdeletions/microduplications
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Microdeletions and microduplications are identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with pathogenic or likely pathogenic microdeletions/microduplications (1-4M) divided by the total number of embryos.
Time frame: Two months after oocyte retrieval
Incidence of heteroploidy
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Heteroploidy is identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with heteroploidy divided by the total number of embryos.
Time frame: Two months after oocyte retrieval
Incidence of loss of heterozygosity
Trophectoderm biopsy samples underwent whole genome amplification followed by NGS. Loss of heterozygosity were identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The incidence will be calculated as the number of embryos with loss of heterozygosity divided by the total number of embryos
Time frame: Two months after oocyte retrieval
Transferable embryo rate
Trophectoderm biopsy samples undergo whole genome amplification followed by NGS. Normal karyotype is identified according to Human Genome Assembly GRCh19 (hg19) or updated versions. The rate will be calculated as the number of embryos with normal karyotype divided by the total number of embryos.
Time frame: Two months after oocyte retrieval
Clinical pregnancy rate
Transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac
Time frame: 28-30 days after embryo transfer
Ongoing pregnancy rate
Transvaginal ultrasonography will be performed. Ongoing pregnancy will be diagnosed with detection of an intrauterine gestational sac
Time frame: 12 weeks after the embryo transfer
Live birth rate
Live birth rate is defined as delivery of any viable infant at 28 weeks or more of gestation, after embryo transfer
Time frame: Two weeks after the newborn's birth
Early miscarriage rate
Number of pregnancy losses / number of clinical pregnancies after transfer
Time frame: 12 weeks of after the embryo transfer
Concordance between prenatal diagnosis results and PGT-A results
Prenatal diagnosis result: Chromosomal analysis performed on fetal samples obtained through chorionic villus sampling or amniocentesis, including karyotyping, chromosomal microarray analysis or next-generation sequencing. PGT-A result: Chromosomal analysis performed by PGT-A upgrade.
Time frame: 16-24 weeks of gestation
Birth defect rate
Physical examination, echocardiography, X-ray/MRI, ophthalmologic examination, hearing screening
Time frame: At 1 year postpartum
Plan to share: No — Considering regulatory requirements, the IPD will not be shared.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Reproductive & Genetic Hospital of CITIC-Xiangya