Blastocyst Euploidy Assessment and Conditioned embryO traNsfer
- Conditions
- Infertility
- Interventions
- Other: PGS
- Registration Number
- NCT02353364
- Lead Sponsor
- Chinese PLA General Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A PGS Transfer of 1 or 2 biopsied euploid embryo of high morphological grade based on NGS testing using CNV-Seq (PGS)
- Primary Outcome Measures
Name Time Method Ongoing pregnancy Gestational week 20
- Secondary Outcome Measures
Name Time Method Genetic health of the fetus Gestational week 18 The patient will be offered a noninvasive prenatal test for fetal aneuploidies between 12-18 weeks gestation
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology
🇨🇳Beijing, China