Preimplantation Diagnosis
Conditions
Brief summary
This study is to compare the efficacy in embryo selection based on morphology alone compared to morphology and non-invasive preimplantation genetic testing for aneuploidy (NIPGT-A) in infertile women undergoing in vitro fertilization (IVF). We supposed the embryo selection based on morphology and NIPGT-A results in a higher live birth rate and a lower miscarriage rate in IVF as compared with that based on morphology alone. Therefore we would like to conduct a double-blind randomized controlled trial. Infertile women undergoing IVF will be enrolled. The spent culture medium (SCM) of each blastocyst will be frozen individually. They will be randomized into two groups: (1) the intervention group based on morphology and NIPGT-A and (2) the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of SCM will be replaced first.The primary outcome is a live birth per the first embryo transfer. We would like to compare live birth rates and miscarriage rates between the two groups.
Interventions
In the intervention group, comprehensive chromosome screening using NGS will be performed according to the recommendations of the company in all SCM samples. Sequence of replacement shall be altered by the NiPGT result after morpholgy.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
* Women aged less than 43 years at the time of ovarian stimulation * At least two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval
Exclusion criteria
* Less than two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval; * Women undergoing PGT for monogenic diseases or structural rearrangement of chromosomes; * Use of donor oocytes; * Hydrosalpinx shown on pelvic scanning and not surgically treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | Number of live births beyond 22 weeks of gestation | Birth beyond 22 weeks of gestation per the first FET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 6 weeks | Presence of intrauterine gestational sac on scanning at gestational week 6 |
| Cumulative live birth rate | Number of pregnancies leading to live birth within 6 months of randomization | Number of pregnancies leading to live birth within 6 months of randomization |
| Time to pregnancy | 1 year | between time of IVF and pregnancy |
| Ongoing pregnancy | 10 weeks | Presence of a fetal pole with pulsation at 8-10 weeks of gestation |
| Positive urine pregnancy test | Positive urine pregnancy test 14 days after embryo transfer | Urine pregnancy test positive |
| Multiple pregnancy | more than one intrauterine sac at 6 weeks | presence of more than one intrauterine sac at 6 weeks of gestation |
| Ectopic pregnancy | 12 weeks | Pregnancy not in the uterus |
| Birth weight | 1 year | Pregnancy outcome |
| Apgar score | 1 year | Pregnancy outcome |
| Miscarriage defined | Pregnancy loss up to 22 weeks | Clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy. |
Countries
China
Outcome results
None listed