NCT06023472 Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
| NCT ID | NCT06023472 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Professor Ernest Hung-Yu Ng |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Infertile women attending for PGT at the Centre of Assisted Reproduction and Embryology, Queen Mary Hospital and Kwong Wah Hospital will be recruited during ovarian stimulation for IVF. Subsequently, they will be randomly assigned on the day of oocyte retrieval by a laboratory staff into one of the following two groups in a 1:1 ratio : (1) the microfluidic chip group and (2) the density gradient centrifugation group for sperm preparation and subsequent use in fertilization. Other IVF procedures will be the same as the standard practice of the Centre. Both women and clinicians will be blinded from the group allocation i.e. a double blind study.
Eligibility Criteria
Inclusion Criteria: * Women aged \<43 years at the time of ovarian stimulation for IVF * Women undergoing PGT for monogenic diseases, structural rearrangement of chromosomes or aneuploidy * Sperm concentration of the raw semen with at least 0.15 million motile sperm per ml or 100 motile sperm per 50 low power field (200x) of observation Exclusion Criteria: * Use of frozen semen for insemination * Use of donor oocytes and spermatozoa * Submucosal fibroid or hydrosalpinx shown on pelvic scanning and not surgically treated; * Women who had been recruited into this study before and * Women joining other randomized trials