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A single center, prospective, randomized clinical study to evaluate the effectiveness of an artificial intelligence-based embryo evaluation model

A single center, prospective, randomized clinical study to evaluate the effectiveness of an artificial intelligence-based embryo evaluation model

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076851
Enrollment
Unknown
Registered
2023-10-22
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility suitable for in vitro fertilization-embryo transfer treatment

Interventions

Experimental Group:Embryo evaluation and selection using the artificial intelligence-based embryo evaluation model
Control Group:Embryo evaluation and selection by an embryologist

Sponsors

The Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Couples with indications for IVF or ICSI, females aged between 20-35; 2. Infertile females undergoing the first cycle of IVF-ET/ICSI-ET treatment; 3. Fully informed consent to this study, and sign the informed consent form; 4. The number of retrieved eggs is =3; 5. Patient embryos were cultured in a Time-lapse closed incubator on Day 0-Day 5; 6. Perform fresh cycle Day 5 single blastocyst transfer and the number of usable blastocysts on Day 5 = 2;

Exclusion criteria

Exclusion criteria: 1. Patients who have been planning to undergo preimplantation genetic testing. 2. Patients diagnosed with uterus abnormality: septate uterus, uterus unicorns, duplex uterus, etc. 3. Patients who have intrauterine adhesions, intrauterine effusion, multiple endometrial polyps, submucosal uterine fibroids, or thin endometrium (endometrial thickness < 7mm on the day of embryo transfer) and other factors that affect embryo implantation; 4. Patients with a history of autoimmune or endocrine diseases: systemic lupus erythematosus (SLE), undifferentiated connective tissue disease (anti-ANA positive), hyperthyroidism, hypothyroidism, etc. 5. At least one of the couple has contraindications to IVF or ICSI, such as poorly controlled type I or type II diabetes, liver disease or abnormal liver function of unknown cause, kidney disease or abnormal renal function, severe anemia, history of deep vein thrombosis, history of pulmonary embolism, history of cerebrovascular accident, poorly controlled hypertension or diagnosed heart disease, history of cervical cancer, endometrial cancer or breast cancer, unexplained vaginal bleeding, severe mental and neurological diseases, etc.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;

Secondary

MeasureTime frame
Biochemistry pregnancy rate;Clinical pregnancy rate;Live birth rate;

Countries

China

Contacts

Public ContactShanshan Wang

The Affiliated Drum Tower Hospital of Nanjing University Medical School

wss_19860820@sina.com+86 138 1454 9922

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026