RCT of NiPGT for Aneuploidy and Morphology Compared with Morphology Alone in IVF

The University of Hong Kong (HKU)

Status: Completed

Conditions: Preimplantation Diagnosis

Treatments: Genetic: Non-invasive Preimplantation genetic testing for aneuploidy status

Study type: Interventional

Funder types: Other

Identifiers

NCT04474522

UW 20-248

Details and patient eligibility

About

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.

Enrollment: 517 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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517 participants in 2 patient groups

intervention group using morphology and NIPGT-A

Active Comparator group

Description:

Both morphology and NIPGT-A result will be used to prioritize the sequence of embryo transfer in the intervention group.

Treatment:

Genetic: Non-invasive Preimplantation genetic testing for aneuploidy status

control group based on morphology alone

No Intervention group

Description:

Morphology only will be used to prioritize the sequence of embryo transfer in the intervention arm.