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Blastocyst Euploidy Assessment and Conditioned embryO traNsfer (BEACON)

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PGS
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Infertility focused on measuring Advanced maternal age, Aneuploidy

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Department of Obstetrics and GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Ongoing pregnancy

Secondary Outcome Measures

Genetic health of the fetus
The patient will be offered a noninvasive prenatal test for fetal aneuploidies between 12-18 weeks gestation

Full Information

First Posted
January 28, 2015
Last Updated
January 28, 2015
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02353364
Brief Title
Blastocyst Euploidy Assessment and Conditioned embryO traNsfer
Acronym
BEACON
Official Title
Prospective Randomised Control Trial of Blastocyst Euploidy Assessment and Conditioned Embryo Transfer for Infertility Patients of Advanced Maternal Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Advanced maternal age, Aneuploidy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Transfer of 1 or 2 biopsied euploid embryo of high morphological grade based on NGS testing using CNV-Seq (PGS)
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Transfer of 1 or 2 non-biopsied embryo of high morphological grade (no PGS)
Intervention Type
Other
Intervention Name(s)
PGS
Intervention Description
Embryos screened by the validated NGS technology CNV-Seq
Primary Outcome Measure Information:
Title
Ongoing pregnancy
Time Frame
Gestational week 20
Secondary Outcome Measure Information:
Title
Genetic health of the fetus
Description
The patient will be offered a noninvasive prenatal test for fetal aneuploidies between 12-18 weeks gestation
Time Frame
Gestational week 18

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Wang, PhD
Email
pkulwang@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Yuanqing, MD
Email
yqyao@126.com
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanqing Yao, MD
Email
yqyao@126.com
First Name & Middle Initial & Last Name & Degree
Li Wang, PhD
Email
pkulwang@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24193117
Citation
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.
Results Reference
background
PubMed Identifier
24998187
Citation
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.
Results Reference
background
PubMed Identifier
24648399
Citation
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.
Results Reference
background
PubMed Identifier
24966395
Citation
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.
Results Reference
background
PubMed Identifier
25160978
Citation
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.
Results Reference
background
PubMed Identifier
32898291
Citation
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.
Results Reference
derived

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Blastocyst Euploidy Assessment and Conditioned embryO traNsfer

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