Blastocyst Euploidy Assessment and Conditioned embryO traNsfer (BEACON)

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown

Phase 1

Conditions

Infertility

Treatments

Other: PGS

Study type

Interventional

Funder types

Other

Identifiers

NCT02353364

PLA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

Female

Ages

35+ years old

Volunteers

No 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