Clinical trial NCT04474522: RCT of niPGT for Aneuploidy and Morphology Compared With Morphology Alone in IVF
Official title: A Randomized Double Blind Controlled Trial of Non-invasive Preimplantation Genetic Testing for Aneuploidy and Morphology Compared With Morphology Alone in in Vitro Fertilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preimplantation Diagnosis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 517
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Live birth
timeFrame: Number of live births beyond 22 weeks of gestation
Secondary outcomes:
measure: Cumulative live birth rate
timeFrame: Number of pregnancies leading to live birth within 6 months of randomization
measure: Time to pregnancy
timeFrame: 1 year
measure: Positive urine pregnancy test
timeFrame: Positive urine pregnancy test 14 days after embryo transfer
measure: Clinical pregnancy
timeFrame: 6 weeks
measure: Ongoing pregnancy
timeFrame: 10 weeks
measure: Miscarriage defined
timeFrame: Pregnancy loss up to 22 weeks
measure: Multiple pregnancy
timeFrame: more than one intrauterine sac at 6 weeks
measure: Ectopic pregnancy
timeFrame: 12 weeks
measure: Birth weight
timeFrame: 1 year
measure: Apgar score
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics and Gynaecology
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ernest HY Ng, MD
role: STUDY_DIRECTOR
References:
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