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A randomized controlled clinical trial of preimplantation screening based on DNA and RNA sequencing

A randomized controlled clinical trial of preimplantation screening based on DNA and RNA sequencing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113137
Enrollment
Unknown
Registered
2025-11-25
Start date
2025-09-03
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Advanced maternal age, recurrent spontaneous miscarriages, repeated implantation failure

Interventions

Control group (PGT-A group):Preimplantation genetic testing for aneuploidy based on DNA sequencing for selecting blastocysts to transfer
Experimental group (DNA and RNA sequencing group):Preimplantation screening based on DNA and RNA sequencing for selecting blastocysts to transfer

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing PGT-A treatment. Indications for PGT-A treatment include advanced maternal age (>=38 years) and/or two or more unexplained recurrent miscarriages, and/or repeated implantation failure (>=3 embryo transfers or failure after transferring 4-6 high-quality cleavage-stage embryos or >=3 high-quality blastocysts); 2.20 years old <= Age of the woman <= 40 years old; 3. On day 5 or 6 of embryo culture, obtaining 2 or more blastocysts with an inner cell mass score of B or above according to the Gardner blastocyst grading system, and a blastocyst expansion grade of 4 or higher; 4. Voluntarily agreeing to participate in this study and signing the informed consent form. If the participant is unable to read the informed consent form (e.g., illiterate participants), the informed consent process must be witnessed and signed by a witness.

Exclusion criteria

Exclusion criteria: 1. Patients with uterine cavity abnormalities, such as congenital uterine malformations (unicorunate, bicornuate, or didelphic uterus); untreated uterine septum or submucosal fibroids; or a history of moderate to severe intrauterine adhesions; 2. Untreated severe tubal hydrops with evidence of hydrosalpinx backflow into the uterine cavity; 3. Patients planning preimplantation genetic testing for structural chromosomal abnormalities (PGT-SR) or preimplantation genetic testing for monogenic disorders (PGT-M), or PGT gender selection due to Y chromosome microdeletion; 4. Patients using donor sperm or donor eggs to achieve pregnancy; 5. Untreated severe medical or surgical conditions; 6. Vulnerable populations, including individuals with mental illnesses, cognitive impairments, critically ill patients, minors, pregnant women, etc.; 7. Other situations that the researchers consider unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Clinica pregnancy rate after the initial embryo transfer;

Secondary

MeasureTime frame
Biochemical pregnancy rate;Implantation rate;Miscarrage rate;Birth weight;Pregnancy and perinatal complication;Live birth rate after the initial embryo transfer;Congenital anomalies;

Countries

China

Contacts

Public ContactSongying Zhang

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

zhangsongying@zju.edu.cn+86 571 86002222

Outcome results

None listed

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