RecruitingNot ApplicableNCT06023472

Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing

A Randomized Comparison of Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing


Sponsor

Professor Ernest Hung-Yu Ng

Enrollment

318 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 43 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DEVICEmicrofluidic chip

Microfluidic chip method has been used for sperm sorting in order to select the most motile and morphologically normal sperm for use in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).

DEVICEdensity gradient centrifugation

Density-gradient centrifugation is a commonly used method for sperm separation and purification. It is a technique that involves layering a semen sample on top of a gradient of different densities of a solution, typically a mixture of colloidal silica and sucrose, and then centrifuging the sample. The centrifugal force causes the sperm to migrate through the gradient, where they become separated based on their density.


Locations(1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

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NCT06023472


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