Blastocyst Euploidy Assessment and Conditioned embryO traNsfer (BEACON)

January 28, 2015 updated by: Dr Li Wang, Chinese PLA General Hospital

Prospective Randomised Control Trial of Blastocyst Euploidy Assessment and Conditioned Embryo Transfer for Infertility Patients of Advanced Maternal Age

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100853
        • Recruiting
        • Department of Obstetrics and gynecology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Embryos screened by the validated NGS technology CNV-Seq
No Intervention: Group B
Transfer of 1 or 2 non-biopsied embryo of high morphological grade (no PGS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy
Time Frame: Gestational week 20
Gestational week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic health of the fetus
Time Frame: Gestational week 18
The patient will be offered a noninvasive prenatal test for fetal aneuploidies between 12-18 weeks gestation
Gestational week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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