NCT04339166

Brief Summary

The objective of this study is to explore whether non-invasive chromosome screening (NICS) can be used as an effective indicator for embryos selection besides morphology through a multicenter randomized controlled trial, by comparing the differences of live birth rate, pregnancy rate and miscarriage rate between the two groups of embryo selection by "NICS+ morphology" and embryo selection only by "morphology" in IVF cycle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

April 1, 2020

Last Update Submit

December 4, 2025

Conditions

InfertilityChromosome Abnormality

Keywords

Culture mediaEmbryonic cell-free DNAEuploidy

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Number of women with ongoing pregnancies after the first transfer/ number of women randomized to the specific group

    12 weeks after the first embryo transfer

Secondary Outcomes (3)

  • Clinical pregnancy rate

    7 weeks after the first embryo transfer

  • Miscarriage rate

    Miscarriage：28 weeks of after the first embryo transfer； First trimester miscarriage(early miscarriage)：12 weeks of after the first embryo transfer；

  • Live birth rate

    within 2 weeks after live birth

Study Arms (2)

Group A

EXPERIMENTAL

Single thawed blastocyst transfer with blastocyst selection according to the analysis of NICS and morphologic score.

Diagnostic Test: Non-invasive chromosome screening（NICS）

Group B

NO INTERVENTION

Single thawed blastocyst transfer with blastocyst selection according to morphologic score.

Interventions

Non-invasive chromosome screening（NICS）DIAGNOSTIC_TEST

NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium

Group A

Eligibility Criteria

Age35 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIVF patients
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle
  • Female age: 35 - 42 years old
  • Women receiving controlled ovarian hyperstimulation treatment (including ultra-long protocol、long-protocol 、short protocol treatment with GnRH agonist and GnRH antagonist treatment protocol); and the number of oocytes ≥6; The female BMI is from 18 to 30kg/m2.
  • Culture embryos to blastocyst stage and all the blastocysts will be single cryopreserved.
  • Single frozen-thawed blastocyst Transferred for the first time
  • The number of blastocysts ≥2, morphology grade (above 4BC/4CB)
  • Written informed consent

You may not qualify if:

  • One of couples with IVF or ICSI contraindications(such as poorly controlled type I or type II diabetes; liver disease or dysfunction; kidney disease or renal function abnormality; significant anemia; history of deep venous thrombosis, pulmonary embolus; history of cerebrovascular accident; uncontrolled hypertension or diagnosed heart disease; history of cervical, endometrial or breast cancer; undiagnosed vaginal bleeding.)
  • PGT cycles
  • Women who have pathologies or malformations that affect the pregnancy outcome: genital malformations, untreated hydrosalpinx, untreated uterine infections, intramural myomas \> 4cm , benign tumor of pelvic and abdominal cavity\> 4cm, intimal thickness\<8mm, pituitary tumors and malignant tumors of various tissues and organs during the patient's participation in the study
  • Untreated hyperprolactinemia, thyroid disease, adrenal disease
  • Women with endometrial polyps that were not treated before embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The First Affiliated Hospital,Sun Yat-sen University

Guanzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Hebei Maternity and Reproductive hospital

Shijiazhuang, Hebei, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Reproductive & Genetic Hospital of Citic-Xiangya

Changsha, Hunan, China

Location

Jinling Hospital,Nanjing University,School Medicine

Nanjing, Jiangsu, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

West China Second Hospital of Sichuan University

Chengdu, Sichuan, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Peking University Third Hospital

Beijing, China

Location

The First Medical Center of Chinese People's Liberation Army General Hospital

Beijing, China

Location

Northwest women's and children's hospital

Xi'an, China

Location

Related Publications (1)

  • Huang J, Rong L, Zeng L, Hu L, Shi J, Cai L, Yao B, Wang XX, Xu Y, Yao Y, Wang Y, Zhao J, Guan Y, Qian W, Hao G, Lu S, Liu P, Qiao J. Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial. BMJ Open. 2022 Jul 27;12(7):e057254. doi: 10.1136/bmjopen-2021-057254.

    PMID: 35896299DERIVED

MeSH Terms

Conditions

InfertilityChromosome Aberrations

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jie Qiao

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 9, 2020

Study Start

April 16, 2020

Primary Completion

February 28, 2024

Study Completion

August 6, 2024

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data may be shared with proper internal and ethical approval. De-identified data may also be shared with approved study investigators.

Shared Documents
STUDY PROTOCOL
Time Frame
After the study has been completed
Access Criteria
Proper internal and ethical approval; protect patient confidentiality; approve by study investigators

Locations

CN(13)