Blastocyst Euploidy Assessment and Conditioned embryO traNsfer

NCT02353364 | Unknown Phase 1 DMC

• 1 other identifier: PLA-001
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

Advanced maternal age; Aneuploidy

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy

  Gestational week 20

Secondary Outcomes (1)

• Genetic health of the fetus

  Gestational week 18

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: PGS

Group B

NO INTERVENTION

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

Interventions

PGS OTHER

Embryos screened by the validated NGS technology CNV-Seq

Group A

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology

Beijing, 100853, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 24193117 BACKGROUND

• 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.

  PMID: 24998187 BACKGROUND

• 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.

  PMID: 24648399 BACKGROUND

• 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.

  PMID: 24966395 BACKGROUND

• 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.

  PMID: 25160978 BACKGROUND

• 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.

  PMID: 32898291 DERIVED

MeSH Terms

Conditions

Infertility; Aneuploidy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Li Wang, PhD

CONTACT

pkulwang@126.com

Yao Yuanqing, MD

CONTACT

yqyao@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGS trial co-ordinator

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

CN (1)