Skip to main content
OpenTrials
Completed

NCT Number: NCT04474522

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preimplantation Diagnosis

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynaecology

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive Preimplantation genetic testing for aneuploidy status

Genetic

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.

Primary outcomes

  1. Live birth

    Time frame: Number of live births beyond 22 weeks of gestation

    Birth beyond 22 weeks of gestation per the first FET

Secondary outcomes

  1. 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

  2. Time to pregnancy

    Time frame: 1 year

    between time of IVF and pregnancy

  3. Positive urine pregnancy test

    Time frame: Positive urine pregnancy test 14 days after embryo transfer

    Urine pregnancy test positive

  4. Clinical pregnancy

    Time frame: 6 weeks

    Presence of intrauterine gestational sac on scanning at gestational week 6

  5. Ongoing pregnancy

    Time frame: 10 weeks

    Presence of a fetal pole with pulsation at 8-10 weeks of gestation

  6. 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.

  7. Multiple pregnancy

    Time frame: more than one intrauterine sac at 6 weeks

    presence of more than one intrauterine sac at 6 weeks of gestation

  8. Ectopic pregnancy

    Time frame: 12 weeks

    Pregnancy not in the uterus

  9. Birth weight

    Time frame: 1 year

    Pregnancy outcome

  10. Apgar score

    Time frame: 1 year

    Pregnancy outcome

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jul 16, 2020
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.