NCT04474522

RCT of niPGT for Aneuploidy and Morphology Compared With Morphology Alone in IVF

A Randomized Double Blind Controlled Trial of Non-invasive Preimplantation Genetic Testing for Aneuploidy and Morphology Compared With Morphology Alone in in Vitro Fertilisation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare the efficacy in embryo selection based on morphology alone compared to morphology and non-invasive preimplantation genetic testing for aneuploidy (NIPGT-A) in infertile women undergoing in vitro fertilization (IVF). We supposed the embryo selection based on morphology and NIPGT-A results in a higher live birth rate and a lower miscarriage rate in IVF as compared with that based on morphology alone. Therefore we would like to conduct a double-blind randomized controlled trial. Infertile women undergoing IVF will be enrolled. The spent culture medium (SCM) of each blastocyst will be frozen individually. They will be randomized into two groups: (1) the intervention group based on morphology and NIPGT-A and (2) the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of SCM will be replaced first.The primary outcome is a live birth per the first embryo transfer. We would like to compare live birth rates and miscarriage rates between the two groups.

Conditions

• Preimplantation Diagnosis

Interventions

Type	Name	Description
GENETIC	Non-invasive Preimplantation genetic testing for aneuploidy status	In the intervention group, comprehensive chromosome screening using NGS will be performed according to the recommendations of the company in all SCM samples. Sequence of replacement shall be altered by the NiPGT result after morpholgy.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-05-30
• Completion: 2025-03-24
• First posted: 2020-07-16
• Last updated: 2025-03-28

Locations

1 site across 1 country: China