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

ConditionsInfertilityGenetic DiseaseChromosomal RearrangementAneuploidy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 43
SponsorProfessor Ernest Hung-Yu Ng

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • microfluidic chip

    Device

    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).

  • density gradient centrifugation

    Device

    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.

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: The microfluidic chip groupExperimental treatment 1 intervention
Group B: The density gradient centrifugation groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Euploid rate of blastocysts

Euploid rate of blastocysts biopsied

Time frame
3 months

Secondary outcomes

1

Live birth rate of the first embryo transfer

No. of live birth beyond 22 weeks of gestation per the first embryo transfer

Time frame
3 years
2

Positive urine pregnancy test rate per the first embryo transfer

No. of positive urine pregnancy test per the first embryo transfer

Time frame
3 years
3

Clinical pregnancy rate of the first embryo transfer

No. of clinical pregnancy per the first embryo transfer defined as presence of intrauterine gestational sac on scanning at gestational week 6.

Time frame
3 years
4

Ongoing pregnancy rate

No. of ongoing pregnancy as presence of a fetal pole with pulsation at 8-10 weeks of gestation

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Professor Ernest Hung-Yu Ng

Lead sponsor

The University of Hong Kong

Sponsor institution

Source ClinicalTrials.gov
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