AI-Assisted Euploid Embryo Selection for Single-Blastocyst Transfer in Women of Advanced Maternal Age
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shanshan Wang
- Telefonnummer: +86-13814549922
- E-post: wss_19860820@sina.com
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210028
- The Affliated Drum Tower Hospital of Nanjing University Medical School
-
Ta kontakt med:
- Shanshan Wang
- Telefonnummer: +86-13814549922
- E-post: wss_19860820@sina.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Sham-komparator: Control
EmbryoInsights™ for AI-assisted morphological assessment |
AI-assisted morphological assessment using EmbryoInsights™ |
|
Eksperimentell: Experimental
EmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction |
AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ongoing pregnancy rate
Tidsramme: 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. |
From enrollment to 12 weeks of gestation ±7 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical pregnancy rate
Tidsramme: From enrollment to 35 days after transfer.
|
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. |
From enrollment to 35 days after transfer.
|
|
Early miscarriage rate
Tidsramme: From confirmation of clinical pregnancy to 12 weeks of gestation
|
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. |
From confirmation of clinical pregnancy to 12 weeks of gestation
|
|
Live birth rate
Tidsramme: At delivery
|
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. |
At delivery
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NDTHNanjingUMS-820
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .