Prospective Randomised Control Trial of Blastocyst Euploidy Assessment and Conditioned Embryo Transfer for Infertility Patients of Advanced Maternal Age
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Ongoing pregnancy
- Last Updated
- 11 years ago
Overview
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.
Investigators
Dr Li Wang
PGS trial co-ordinator
Chinese PLA General Hospital
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)
Outcomes
Primary Outcomes
Ongoing pregnancy
Time Frame: Gestational week 20
Secondary Outcomes
- Genetic health of the fetus(Gestational week 18)