Preimplantation genetic testing guides the clinical evaluation of abnormal IVF fertilization (zero and single pronucleus) embryos and the follow-up of pregnancy after single embryo transfer

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100044746

Enrollment

Unknown

Registered

2021-03-26

Start date

2021-11-01

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

abnormal IVF fertilization (zero and single pronucleus)

Interventions

Gold Standard:Preimplantation genetic testing-aneuploidy screening (PGT-A), Equipment: Ilumina next-generation sequencing diagnostic platform.

Index test:Noninvasive PGT-A, niPGT-A.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.For patients entering the clinical cycle of ovulation induction, in vitro fertilization, and embryo transfer, the insemination method is IVF, or IVF fertilization in half-ICSI; 2.Observation of fertilization and embryo development from Day1 to Day3: (1)zero pronucleus: embryo on Day1 is 0PN (MII-1pb or MII-2pb), embryo on Day3 is cleavage embryo; (2)single pronucleus:embryo on Day1 is 1PN (1PN-1pb or 1PN-2pb), embryo on Day3 is cleavage embryo; 3.Clinical inclusion criteria: embryo from 0PN or 1PN on Day3 is cleavage embryo in 4-cell grade II or above, which will be performed blastocyst culture; 4.Patients who have the requirement of prenatal and postnatal care voluntarily participate in this study and sign the informed consent; 5.Enrollment criteria of IVF lab.: blastocysts were observed from Day5 to Day6 (score was above CC level), blastocyst biopsy and culture drops collection were performed.

Exclusion criteria

Exclusion criteria: 1.Observation of fertilization and embryo development from Day1 to Day3: (1)2PN or multiple prokaryotic fertilization (>= 3PN) on Day 1; (2)Unfertilized oocytes (MII, MI or GV) on Day3; (3)Embryo from single pronucleus on Day1 is not cleaved until Day3.

Design outcomes

Primary

Measure	Time frame
clinical pregnancy rate;miscarriage rate;	—

Secondary

Measure	Time frame
The rate of delivery that lasts from pregnancy to delivery;type of abnormal fertillization;Score of transferred embryo;result of PGT-A;result of serum HCG;	—

Countries

China

Contacts

Public ContactYuan Ping

IVF Center, Department of Obstetrics and Gynecology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University

kekeyp1983@163.com+86 137 5188 5713

Outcome results

None listed

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