CClinicalTrials.gg
Sign In
Status unknownNCT02353364BEACONUpdated Feb 2, 2015

Blastocyst Euploidy Assessment and Conditioned embryO traNsfer

A Phase 1 interventional study of PGS in Infertility, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2015-02-02.

Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
35 Years and older
Sex
Female
01

Study summary

The study is designed to evaluate the effectiveness of pre-implantation genetic screening (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive treatment. Half of the patients will have their embryos tested by PGS and 1 or 2 chromosomally normal embryos with the highest morphological grading transplanted back to the uterus. The other half of the participants will not have their embryos tested and 1 or 2 untested embryos with the highest morphological grading transplanted back to the uterus.

Read the detailed description

PGS is an assisted reproductive technology that screens patients embryos, discriminating between embryos with a normal set of chromosomes (euploid) and those with an abnormal set of chromosomes (aneuploid). In this study, we will apply a novel validated next generation sequencing technology called copy number variation sequencing (CNV-Seq) to comprehensively screen a trophectoderm biopsy sample from patient's embryos for chromosomal abnormalities that commonly arise in human embryos. The hypothesis is that PGS performed using CNV-Seq on embryos produced by patients with a poor prognosis for pregnancy (maternal age > 35), followed by transfer of chromosomally normal euploid embryos, will result in significantly higher implantation, pregnancy and live birth rates and lower miscarriage rates compared to patients having no PGS.

02

Conditions studied

  • Infertility

Browse trials for

Keywords

  • Advanced maternal age
  • Aneuploidy
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patient undergoing in vitro fertilization (IVF)
  • Normal uterine function by ultrasound and absence of hysteromyoma
  • Regular menstrual cycle of 25-35 days
  • Normal hormone levels (WHO standard) for LH, PRL, E2, PROG, TEST and TSH
  • FSH 1-12 IU/L and follicle number > 5 on day 2-3 of menstrual cycle
  • Minimum of 3 blastocysts on day 5 of embryo development
  • Signed consent form

Exclusion criteria

Exclusion Criteria:

  • Known endometriosis
  • Abnormal vaginal bleeding with no known cause
  • Known genital organ system malformation, unsuitable to conceive
  • Known currently active pelvic inflammation
  • Abnormal liver, kidney lab results, with clinical implications.
  • Known endocrine or metabolic disorders (pituitary gland, adrenal glands, pancreas, liver or kidney）
  • Known ovarian, breast, uterine, adrenal glands, pituitary gland or hypothalamus tumor
  • Known abnormal cervical cancer lesions, with clinical implications, within one year before PGS
  • History of chemo- or radio-therapy
  • Seropositive for HIV, Hep B, Hep C or TPPA/RPR (Syphilis)
  • Known ovarian poor response in previous cycles, i.e. after administration of GnRH for > 20 days
  • More than 2 implantation failures
  • More than 2 miscarriages
  • Known altered parental karyotype such as Robertsonian or reciprocal translocation
  • Use of sperm or oocyte donors
  • Severe male factor (surgical retrieval of sperm)
  • Preimplantation genetic diagnosis cycles for single gene diseases or sex selection
  • Participation in other IVF research studies
  • Patient refusal or inability to follow the protocol for any good reason, including clinical visit or lab test
05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Group A

    Transfer of 1 or 2 biopsied euploid embryo of high morphological grade based on NGS testing using CNV-Seq (PGS)

    Other: PGS

  • No intervention
    Group B

    Transfer of 1 or 2 non-biopsied embryo of high morphological grade (no PGS)

Interventions

  • OtherPGS

    Embryos screened by the validated NGS technology CNV-Seq

06

What researchers measure

Primary outcomes

  1. Ongoing pregnancy

    Time frame: Gestational week 20

Secondary outcomes

  1. Genetic health of the fetus

    The patient will be offered a noninvasive prenatal test for fetal aneuploidies between 12-18 weeks gestation

    Time frame: Gestational week 18

07

Study locations

1 of 1 sites recruiting
  • Department of Obstetrics and Gynecology
    Beijing, 100853, China
    Recruiting
08

References and documents

Publications

  • Wang Y, Chen Y, Tian F, Zhang J, Song Z, Wu Y, Han X, Hu W, Ma D, Cram D, Cheng W. Maternal mosaicism is a significant contributor to discordant sex chromosomal aneuploidies associated with noninvasive prenatal testing. Clin Chem. 2014 Jan;60(1):251-9. doi: 10.1373/clinchem.2013.215145. Epub 2013 Nov 5. PubMed 24193117 ↗
  • Liang D, Peng Y, Lv W, Deng L, Zhang Y, Li H, Yang P, Zhang J, Song Z, Xu G, Cram DS, Wu L. Copy number variation sequencing for comprehensive diagnosis of chromosome disease syndromes. J Mol Diagn. 2014 Sep;16(5):519-526. doi: 10.1016/j.jmoldx.2014.05.002. Epub 2014 Jul 3. PubMed 24998187 ↗
  • Wang L, Wang X, Zhang J, Song Z, Wang S, Gao Y, Wang J, Luo Y, Niu Z, Yue X, Xu G, Cram DS, Yao Y. Detection of chromosomal aneuploidy in human preimplantation embryos by next-generation sequencing. Biol Reprod. 2014 May 8;90(5):95. doi: 10.1095/biolreprod.113.116459. Print 2014 May. PubMed 24648399 ↗
  • Wang L, Cram DS, Shen J, Wang X, Zhang J, Song Z, Xu G, Li N, Fan J, Wang S, Luo Y, Wang J, Yu L, Liu J, Yao Y. Validation of copy number variation sequencing for detecting chromosome imbalances in human preimplantation embryos. Biol Reprod. 2014 Aug;91(2):37. doi: 10.1095/biolreprod.114.120576. Epub 2014 Jun 25. PubMed 24966395 ↗
  • Wang H, Wang L, Ma M, Song Z, Zhang J, Xu G, Fan J, Li N, Cram DS, Yao Y. A PGD pregnancy achieved by embryo copy number variation sequencing with confirmation by non-invasive prenatal diagnosis. J Genet Genomics. 2014 Aug 20;41(8):453-6. doi: 10.1016/j.jgg.2014.06.007. Epub 2014 Jul 17. No abstract available. PubMed 25160978 ↗
  • Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3. PubMed 32898291 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02353364
Lead sponsor
Chinese PLA General Hospital
Responsible party
Dr Li Wang (PGS trial co-ordinator, Chinese PLA General Hospital) — Principal investigator
First posted
Feb 2, 2015
Start date
Nov 2014
Primary completion
Dec 2015 (estimated)
Completion
Oct 2016 (estimated)
Last update
Feb 2, 2015

Study contacts

Li Wang, PhD
Contact
pkulwang@126.com
Yao Yuanqing, MD
Contact
yqyao@126.com

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infertility→

Other studies from this sponsor

Chinese PLA General Hospital

Start the discussion