About this trial

Infertile patients attending IVF treatment 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: (1) the microfluidic chip group and (2) the density gradient group for sperm preparation and subsequent use in fertilization. Other IVF procedures will be the same as our usual practice. Both patients and clinicians were blinded from the group allocation i.e. a double blind study. The primary outcome is the cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infertile women aged <43 years at the time of ovarian stimulation for IVF

Disqualifiers

Women undergoing preimplantation genetic testing monogenic diseases, structural rearrangement of chromosomes or aneuploidy;

Male factor requiring surgical sperm retrieval such as microscopic epididymal sperm aspiration and testicular sperm extraction;

Use of donor oocytes and spermatozoa;

Submucosal fibroid or hydrosalpinx shown on pelvic scanning and not surgically treated;

Trial design

Design model

Parallel

Treatments tested in this trial

Microfluidic chip
Device
The Sperm Separation Device - ZyMōt Multi 850µL (ZyMōt Fertility, Inc) will be used. The microfluidics chamber will be used according to the manufacturer's instructions. 850 μL of the semen sample will be inserted into the inlet port of the device and 750 μL of fertilization media will be inserted into the outlet port. The device with the semen sample inside will be incubated in 6% CO2 at 37°C. After 30 min, 500 μL of the sample at the outlet port will be removed from the outlet port and pipetted into a labelled test tube.
Density-gradient centrifugation
Device
After liquefaction, sperm preparation will be completed by a discontinuous density gradient centrifugation method, using Pureception (CooperSurgical, Denmark) sperm density gradient media. The resulting sperm pellet after centrifugation will be washed once with the sperm washing medium (G-IVF Plus, Vitrolife, Sweden) The washed spermatozoa will be resuspended with the same medium, adjusting the final volume to 0.5 mL.

Treatment groups

1,136 Participants

are divided into 2 treatment groups

Group A: microfluidic chip methodExperimental treatment 1 intervention

Group B: density-gradient centrifugation methodActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

cumulative live birth rate

cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.

Time frame

within 6 months of randomisation.

Secondary outcomes

1

Live birth beyond 22 weeks of gestation per the first embryo transfer or FET

Time frame

3 years

2

Positive urine pregnancy test per the first embryo transfer or FET

Time frame

3 years

3

Clinical pregnancy per the first embryo transfer or FET defined as presence of intrauterine gestational sac on scanning at gestational week 6.

Time frame

3 years

4

Ongoing pregnancy rate as presence of a fetal pole with pulsation at 8-10 weeks of gestation

Time frame

3 years

Microfluidic Chip Method Versus Density-gradient Centrifugation Method in IVF

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts