Prospective International Multi-center Clinical Trial of PGT-A Upgrade
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-46
SponsorReproductive & Genetic Hospital of CITIC-Xiangya
About this trial
The goals of this international multicenter cross-sectional study are:
1. To provide patients with a comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and heterozygosity (LOH) in a single assay, thereby reducing miscarriage and birth defects; 2. To perform PGT analysis on abnormally fertilized embryos, select euploid embryos with normal ploidy, and calculate embryo utilization rates; 3. To reduce the false-positive rate through confirmation of mosaic embryos and subsequent analysis of its origin, thereby minimizing embryo wastage; 4. To provide molecular genetic evidence for expert consensus on clinical management of atypically fertilized embryos, of pathogenic/likely pathogenic small CNVs, optimize mosaic embryo transfer strategies, and inform preconception intervention; 5. To enhance international PGT testing standards through international multi-center collaboration.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
advanced maternal age (AMA, age ≥35 years),
recurrent implantation failure (RIF),
recurrent miscarriage (RM),
severe male factor (SMF). (2) And at least one blastocyst is available.
Disqualifiers
Couples undergoing PGT-SR due to chromosomal structural abnormalities carried by either one or both members, such as balanced translocations, Robertsonian translocations, inversions, complex chromosomal rearrangements, and pathogenic microdeletions or microduplications;
Couples undergoing PGT-M;
Conditions with established impact on uterine morphology or endometrial receptivity, including untreated uterine malformations (septate uterus, unicornuate uterus, didelphic uterus, etc.) and untreated hydrosalpinx;
Embryos coming from oocyte or sperm (gametes) donation;
Trial population
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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
PGT-A upgrade
Other interventionA comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and LOH in a single assay.
Treatment groups
1,700 Participants
are divided into 1 treatment groupGroup A: PGT-A upgrade group1 intervention
Trial outcomes
Primary outcomes
1
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 retrieval2
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 retrieval3
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 retrievalSecondary outcomes
1
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 retrieval2
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 transfer3
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 transfer4
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 birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Reproductive & Genetic Hospital of CITIC-Xiangya
Lead sponsor
The First People's Hospital of Yunnan
Collaborator
Nanjing Women and Children's Healthcare Hospital
Collaborator
Biocódices
Collaborator
Miracle
Collaborator
Institute Bernabéu
Collaborator
Thomson Hospital
Collaborator
Source ClinicalTrials.gov
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