Official Title
A Multicenter Clinical Study on Embryo Selection by Using the Ploidy of Cell Free DNA in Embryo Culture Medium
Brief Title
Embryo Selection by Noninvasive Preimplantation Genetic Test
Protocol ID
NCT04339166
Lead Sponsor
Peking University Third Hospital
Brief Summary
The objective of this study is to explore whether non-invasive chromosome screening
(NICS) can be used as an effective indicator for embryos selection besides morphology
through a multicenter randomized controlled trial, by comparing the differences of live
birth rate, pregnancy rate and miscarriage rate between the two groups of embryo
selection by "NICS+ morphology" and embryo selection only by "morphology" in IVF cycle.
Detailed Description
Chromosomal abnormalities commonly exist in early human embryos, and often cause embryo
implantation failure and pregnancy loss in in-vitro fertilization (IVF) treatments.
Preimplantation genetic testing for aneuploidies (PGT-A) by comprehensive chromosome
screening (CCS) has been widely applied in IVF practices to select embryos with normal
ploidy. Although multiple clinical trials have demonstrated improved clinical outcomes
with PGT-A, it's in controversial for whether PGT-A is truly worthwhile to be offered to
all IVF patients. One of the main concerns is that it involves an embryo biopsy
procedure, which is invasive and the long-term safety issue of the embryo biopsy remains
to be fully investigated.
In recent years, researchers have found that the spent medium of embryo culture contains
trace amount of cell-free DNA, which may reflect the ploidy of the embryo. The
non-invasive chromosome screening (NICS) approach utilizing spent culture medium samples
has been evaluated in studies. However, the clinical value of NICS as a new effective
indicator to evaluate embryo competence so far has not been justified by randomized
clinical trials.
The main purpose of this project is to verify whether NICS can be used as a new effective
indicator for evaluating embryo developmental potential through multi-center, randomized
clinical trials
Study Period
-
Enrollment Count
1,152 participants
Eligibility Criteria
Inclusion Criteria:
1. Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle
2. Female age: 35 - 42 years old
3. Women receiving controlled ovarian hyperstimulation treatment (including ultra-long
protocol、long-protocol 、short protocol treatment with GnRH agonist and GnRH
antagonist treatment protocol); and the number of oocytes ≥6; The female BMI is from
18 to 30kg/m2.
4. Culture embryos to blastocyst stage and all the blastocysts will be single
cryopreserved.
5. Single frozen-thawed blastocyst Transferred for the first time
6. The number of blastocysts ≥2, morphology grade (above 4BC/4CB)
7. Written informed consent
Exclusion Criteria:
1. One of couples with IVF or ICSI contraindications(such as poorly controlled type I
or type II diabetes; liver disease or dysfunction; kidney disease or renal function
abnormality; significant anemia; history of deep venous thrombosis, pulmonary
embolus; history of cerebrovascular accident; uncontrolled hypertension or diagnosed
heart disease; history of cervical, endometrial or breast cancer; undiagnosed
vaginal bleeding.)
2. PGT cycles
3. Women who have pathologies or malformations that affect the pregnancy outcome:
genital malformations, untreated hydrosalpinx, untreated uterine infections,
intramural myomas > 4cm , benign tumor of pelvic and abdominal cavity> 4cm, intimal
thickness<8mm, pituitary tumors and malignant tumors of various tissues and organs
during the patient's participation in the study
4. Untreated hyperprolactinemia, thyroid disease, adrenal disease
5. Women with endometrial polyps that were not treated before embryo transfer
Filters
Infertility
Chromosome Abnormality
NA
COMPLETED
ADULT