New embryo genetic test aims to cut miscarriages and birth defects
NCT ID NCT07533630
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test an upgraded genetic test (PGT-A upgrade) on embryos from 1,700 IVF patients across multiple countries. The test looks for a wider range of chromosomal issues than standard tests. Researchers hope this will help select healthier embryos, reducing the chance of miscarriage and birth defects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PGT-A upgrade genetic test
- What this could lead to
- If successful, this could improve embryo selection in IVF, potentially lowering miscarriage and birth defect rates.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly improve pregnancy outcomes, and results may take years to apply clinically.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,700 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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20 to 46 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: (1) Any one of the following conditions being met is sufficient: 1. advanced maternal age (AMA, age ≥35 years), 2. recurrent implantation failure (RIF), 3. recurrent miscarriage (RM), 4. severe male factor (SMF). (2) And at least one blastocyst is available. Exclusion Criteria: 1. 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; 2. Couples undergoing PGT-M; 3. Conditions with established impact on uterine morphology or endometrial receptivity, including untreated uterine malformations (septate uterus, unicornuate uterus, didelphic uterus, etc.) and untreated hydrosalpinx; 4. Embryos coming from oocyte or sperm (gametes) donation; 5. Individuals with contraindications to pregnancy or assisted reproduction technology.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Biocódices
Buenos Aires, Argentina
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CITIC-Xiangya Reproductive & Genetic Hospital
Changsha, Hunan, China
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First People's Hospital of Yunnan Province
Kunming, Yunnan, China
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Institute Bernabéu
Alicante, Spain
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Miracle
Daegu, South Korea
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Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu, China
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Thomson Hospital
Petaling Jaya, Malaysia
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Other studies related to the condition(s) this trial covers.
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- 5,000 patients join study to uncover why fertility treatments fail
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