RCT of NiPGT for Aneuploidy and Morphology Compared with Morphology Alone in IVF

March 24, 2025 updated by: Professor Ernest Hung-Yu Ng, The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

517

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Department of Obstetrics and Gynaecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged less than 43 years at the time of ovarian stimulation
  • At least two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval

Exclusion Criteria:

  • Less than two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval;
  • Women undergoing PGT for monogenic diseases or structural rearrangement of chromosomes;
  • Use of donor oocytes;
  • Hydrosalpinx shown on pelvic scanning and not surgically treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention group using morphology and NIPGT-A
Both morphology and NIPGT-A result will be used to prioritize the sequence of embryo transfer in the intervention group.
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.
No Intervention: control group based on morphology alone
Morphology only will be used to prioritize the sequence of embryo transfer in the intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth
Time Frame: Number of live births beyond 22 weeks of gestation
Birth beyond 22 weeks of gestation per the first FET
Number of live births beyond 22 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ectopic pregnancy
Time Frame: 12 weeks
Pregnancy not in the uterus
12 weeks
Cumulative live birth rate
Time Frame: Number of pregnancies leading to live birth within 6 months of randomization
Number of pregnancies leading to live birth within 6 months of randomization
Number of pregnancies leading to live birth within 6 months of randomization
Time to pregnancy
Time Frame: 1 year
between time of IVF and pregnancy
1 year
Positive urine pregnancy test
Time Frame: Positive urine pregnancy test 14 days after embryo transfer
Urine pregnancy test positive
Positive urine pregnancy test 14 days after embryo transfer
Clinical pregnancy
Time Frame: 6 weeks
Presence of intrauterine gestational sac on scanning at gestational week 6
6 weeks
Ongoing pregnancy
Time Frame: 10 weeks
Presence of a fetal pole with pulsation at 8-10 weeks of gestation
10 weeks
Miscarriage defined
Time Frame: Pregnancy loss up to 22 weeks
Clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.
Pregnancy loss up to 22 weeks
Multiple pregnancy
Time Frame: more than one intrauterine sac at 6 weeks
presence of more than one intrauterine sac at 6 weeks of gestation
more than one intrauterine sac at 6 weeks
Birth weight
Time Frame: 1 year
Pregnancy outcome
1 year
Apgar score
Time Frame: 1 year
Pregnancy outcome
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Study Director: Ernest HY Ng, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

March 24, 2025

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 20-248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preimplantation Diagnosis

Clinical Trials on Non-invasive Preimplantation genetic testing for aneuploidy status

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe