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The Impact of NICS Testing of Frozen-Thawed Embryos on Pregnancy Outcomes in High-Age IVF Patients: A Multicenter Prospective Study

The impact of NICS testing of frozen-thawed embryos in elderly IVF patients on clinical pregnancy outcomes in the transfer cycle: A multicenter prospective real-world clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120236
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Advanced Maternal Age Infertility (>=35 years)

Interventions

NICS Group:Thawing—short-term recovery culture—collection of recovery culture medium for NICS testing—re-freezing strategy
in subsequent FET cycles, embryo selection based on NICS-AI grading (A>B>C) combined with morphological assessment, followed by single blastocyst frozen embryo transfer.
Control Group (Traditional Morphology Group):No NICS screening
direct embryo selection based on traditional morphological grading of frozen embryos, followed by single blastocyst frozen embryo transfer.

Sponsors

Hebei Reproductive and Obstetrics Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Infertile couples who receive ICSI or IVF assisted reproductive technology, excluding egg/sperm donation cycles; 2. Female age >=35 years old (based on the date of egg retrieval); 3. There is a history of failed embryo transfer (fresh embryo/frozen embryo) (non-pregnancy/biochemical pregnancy/miscarriage/fetal arrest), including 1-2 failed transfers or 1 miscarriage, and the chromosomal test of the miscarriage product is positive. 4. The female body mass index (BMI) is between 18 and 30 kg/m^2. 5. The number of remaining frozen blastocysts is >=2 and the blastocyst days are all D5/D6. Or, after culturing blastocysts from frozen cleaved embryos, the total number of blastocysts tested is >=2. The blastocyst rating should be 4BC/4CB or above. 6. The first transfer after enrollment was single blastocyst transfer; 7. The karyotypes of the couple are normal.

Exclusion criteria

Exclusion criteria: 1. Diseases that are not suitable for IVF or ICSI, such as liver disease, kidney disease, type 1 or type 2 diabetes, heart disease, anemia, poorly controlled hypertension, history of cerebrovascular events, history of deep vein thrombosis and/or pulmonary embolism, history of cervical cancer, endometrial cancer or breast cancer, and undiagnosed vaginal bleeding; 2. Anyone who has undergone or plans to undergo preimplantation genetic testing/screening in previous cycles: PGT-A/PGT-M/PGT-SR (including those to be conducted this time) or has undergone NICS for this batch of embryos in the past; 3. Pathological conditions that may affect pregnancy outcomes, including genital malformations, hydrosalpinx, intrauterine infections, uterine fibroids with a diameter greater than 4 cm, benign pelvic or abdominal tumors with a diameter greater than 4 cm, endometrial thickness less than 7 mm that cannot be improved, pituitary tumors and malignant tumors; 4. Untreated hyperprolactinemia, thyroid diseases and adrenal diseases; 5. Endometrial polyps that were not treated before the thawing and transplantation cycle; 6. Patients with repeated implantation failure (failure to achieve clinical pregnancy after at least three high-quality embryos have been transplanted in three fresh or frozen cycles) and those with repeated miscarriage (two or more consecutive miscarriages before 20 weeks).

Design outcomes

Primary

MeasureTime frame
Continuing pregnancy rate at 12 weeks of gestation;

Secondary

MeasureTime frame
Clinical pregnancy rate;Spontaneous abortion rate;Live birth rate;Neonatal outcomes;

Countries

China

Contacts

Public ContactCai Liyi

Hebei Reproductive and Obstetrics Hospital

fjwx@sjzkj.gov.cn+86 18031861808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026