Female InfertilityNCT07833345
AI-Assisted Euploid Embryo Selection for Single-Blastocyst Transfer in Women of Advanced Maternal Age
A study testing AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus and AI-assisted morphological assessment using EmbryoInsights™ in people with Female Infertility, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This single-center prospective randomized controlled study will enroll 500 infertile women aged 35 years or older who meet the criteria for fresh day-5 single-blastocyst transfer. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus and AI-assisted morphological assessment using EmbryoInsights™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Infertile women aged ≥35 years. (2) Planned IVF or ICSI. (3) No more than two previous oocyte-retrieval cycles. (4) At least three usable day-3 embryos and eligibility for day-5 single-blastocyst transfer. (5) At least one day-5 blastocyst meeting transfer criteria, Gardner grade ≥3BB. (6) Voluntary written informed consent from both partners.
Who cannot join
- (1) PGT required because of chromosomal abnormalities. (2) Donor-oocyte, donor-sperm or thawed-oocyte cycles. (3) Severe uterine malformations, intrauterine adhesions, or infertility attributable solely to uterine factors. (4) Incomplete or unclear blastocyst images affecting AI assessment. (5) Other circumstances judged unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210028
Shanshan Wang, +86-13814549922, wss_19860820@sina.com
About this study
Official title: Effects of Multimodal AI-Assisted Noninvasive Euploid Embryo Selection on Clinical Outcomes After Single-Blastocyst Transfer in Women of Advanced Maternal Age: A Prospective Randomized Controlled Trial
This single-center prospective randomized controlled study will enroll 500 infertile women aged 35 years or older who meet the criteria for fresh day-5 single-blastocyst transfer. Participants will be allocated 1:1 to AI-assisted morphological assessment using EmbryoInsights™ or AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus. The study evaluates whether adding euploidy prediction improves ongoing pregnancy after the first fresh transfer. Secondary outcomes are clinical pregnancy, early miscarriage and live birth. Maternal and infant safety will be monitored.
Read the detailed description
After routine ovarian stimulation, oocyte retrieval and IVF/ICSI, embryos will undergo closed time-lapse culture. Patients will be recruited and provide informed consent on day 3. Eligible patients will be randomized by the random envelope method in a 1:1 ratio on day 5. The control group uses EmbryoInsights™ for morphological assessment. The experimental group uses EmbryoInsights™ Plus to predict euploidy probability and rank morphologically transferable blastocysts, prioritizing those classified as predicted euploid and then using morphology. Senior embryology professionals and study clinicians make the final transfer decision. If AI results are unavailable or the system fails, routine manual assessment is used. An AI result alone does not automatically cancel transfer. The investigational euploidy-prediction model has already been developed. No additional embryo biopsy or biological sampling is required. Follow-up includes hCG at 14 days after transfer, ultrasound at 35 days, assessment at 12 gestational weeks (±7 days), fetal anatomy assessment at 20-24 weeks, delivery, and 42 days postpartum. The primary analysis of ongoing pregnancy will use the intention-to-treat (ITT) population, with all randomized participants analyzed in their originally assigned groups. A per-protocol (PP) analysis will also be performed.
- Conditions
- Female Infertility
- Being tested
- AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus, AI-assisted morphological assessment using EmbryoInsights™
- Keywords
- Female Infertility, Advanced Maternal Age, Embryonic Aneuploidy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ PlusOther
AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus
AI-assisted morphological assessment using EmbryoInsights™Other
AI-assisted morphological assessment using EmbryoInsights™
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | EmbryoInsights™ for AI-assisted morphological assessment Receives: Other: AI-assisted morphological assessment using EmbryoInsights™ |
| Experimental | Experimental | EmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction Receives: Other: AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ongoing pregnancy is defined as pregnancy reaching 12 weeks of gestation after transfer, with fetal cardiac activity confirmed by ultrasound. The ongoing pregnancy rate is the proportion of transfer cycles in the group that achieve ongoing pregnancy. This outcome is the sole basis for sample size estimation in this study. Assessment: ultrasound at 12 weeks of gestation ±7 days.
Measured: From enrollment to 12 weeks of gestation ±7 days
Secondary outcomes (3)
Clinical pregnancy rate
Number of cycles with an intrauterine gestational sac detected by ultrasound at 6-8 weeks of gestation / total number of transfer cycles in the group ×100%. Assessment: ultrasound 35 days after transfer.
Measured: From enrollment to 35 days after transfer.
Early miscarriage rate
Number of cycles with pregnancy loss after confirmation of clinical pregnancy and within 12 weeks of gestation / total number of clinical pregnancy cycles in the group ×100%. Assessment period: from confirmation of clinical pregnancy to 12 weeks of gestation.
Measured: From confirmation of clinical pregnancy to 12 weeks of gestation
Live birth rate
Number of cycles resulting in delivery of a live infant at ≥24 weeks of gestation / total number of transfer cycles in the group ×100%. Assessment: at delivery.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833345
- Sponsor's protocol ID
- NDTHNanjingUMS-820
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal AI-Assisted Noninvasive Euploid Embryo Selection on Clinical Outcomes After Single-Blastocyst Transfer in Women of Advanced Maternal Age: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07833345
- Acronym / sponsor ID
- NDTHNanjingUMS-820
- Conditions
- Female Infertility
- Keywords
- Female Infertility, Advanced Maternal Age, Embryonic Aneuploidy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center prospective randomized controlled study will enroll 500 infertile women aged 35 years or older who meet the criteria for fresh day-5 single-blastocyst transfer. Participants will be allocated 1:1 to AI-assisted morphological assessment using EmbryoInsights™ or AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus. The study evaluates whether adding euploidy prediction improves ongoing pregnancy after the first fresh transfer. Secondary outcomes are clinical pregnancy, early miscarriage and live birth. Maternal and infant safety will be monitored.
Detailed description
After routine ovarian stimulation, oocyte retrieval and IVF/ICSI, embryos will undergo closed time-lapse culture. Patients will be recruited and provide informed consent on day 3. Eligible patients will be randomized by the random envelope method in a 1:1 ratio on day 5. The control group uses EmbryoInsights™ for morphological assessment. The experimental group uses EmbryoInsights™ Plus to predict euploidy probability and rank morphologically transferable blastocysts, prioritizing those classified as predicted euploid and then using morphology. Senior embryology professionals and study clinicians make the final transfer decision. If AI results are unavailable or the system fails, routine manual assessment is used. An AI result alone does not automatically cancel transfer. The investigational euploidy-prediction model has already been developed. No additional embryo biopsy or biological sampling is required. Follow-up includes hCG at 14 days after transfer, ultrasound at 35 days, assessment at 12 gestational weeks (±7 days), fetal anatomy assessment at 20-24 weeks, delivery, and 42 days postpartum. The primary analysis of ongoing pregnancy will use the intention-to-treat (ITT) population, with all randomized participants analyzed in their originally assigned groups. A per-protocol (PP) analysis will also be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: AI-assisted morphological assessment using EmbryoInsights™EmbryoInsights™ for AI-assisted morphological assessment |
| Experimental | Experimental | Other: AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ PlusEmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Infertile women aged ≥35 years. (2) Planned IVF or ICSI. (3) No more than two previous oocyte-retrieval cycles. (4) At least three usable day-3 embryos and eligibility for day-5 single-blastocyst transfer. (5) At least one day-5 blastocyst meeting transfer criteria, Gardner grade ≥3BB. (6) Voluntary written informed consent from both partners.
Key exclusion criteria (1 listed)
- (1) PGT required because of chromosomal abnormalities. (2) Donor-oocyte, donor-sperm or thawed-oocyte cycles. (3) Severe uterine malformations, intrauterine adhesions, or infertility attributable solely to uterine factors. (4) Incomplete or unclear blastocyst images affecting AI assessment. (5) Other circumstances judged unsuitable by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ PlusAI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus | Other | Experimental |
| AI-assisted morphological assessment using EmbryoInsights™AI-assisted morphological assessment using EmbryoInsights™ | Other | Control |
Primary outcome
Ongoing pregnancy rate
Time frame: From enrollment to 12 weeks of gestation ±7 days
Ongoing pregnancy is defined as pregnancy reaching 12 weeks of gestation after transfer, with fetal cardiac activity confirmed by ultrasound. The ongoing pregnancy rate is the proportion of transfer cycles in the group that achieve ongoing pregnancy. This outcome is the sole basis for sample size estimation in this study. Assessment: ultrasound at 12 weeks of gestation ±7 days.
3 secondary outcomes
Clinical pregnancy rate
Time frame: From enrollment to 35 days after transfer.
Early miscarriage rate
Time frame: From confirmation of clinical pregnancy to 12 weeks of gestation
Live birth rate
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus and AI-assisted morphological assessment using EmbryoInsights™ in people with Female Infertility, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Wang (+86-13814549922, wss_19860820@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: From enrollment to 12 weeks of gestation ±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.