InfertilityNCT06005311
Microfluidic Chip Method Versus Density-gradient Centrifugation Method in IVF
A study testing Microfluidic chip and Density-gradient centrifugation in people with Infertility, run by Professor Ernest Hung-Yu Ng at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 43 years
- Conditions the study is for
- Infertility
- What is being tested?
- Microfluidic chip and Density-gradient centrifugation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,136 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 43 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Infertile women aged <43 years at the time of ovarian stimulation for IVF
Who cannot join
- 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;
- Women who had been recruited into this study before and
- Women joining other randomized trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong
Ernest HY NG, MD, 852-22553400, nghye@hku.hk
Ernest HY NG, MD
About this study
Official title: A Randomized Double-blind Controlled Study of the Cumulative Live Birth Rate of IVF Following Sperm Preparation by Microfluidic Chip Method Versus Density-gradient Centrifugation Method
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.
Read the detailed description
The trial will compare the use of a microfluidic chip with the use of density gradient centrifugation for sperm preparation.
The hypothesis of the study is that the use of the microfluidic chip will improve the cumulative live birth rate of IVF compared to the density gradient method.
The trial will be conducted at the Centre of Assisted Reproduction and Embryology at Queen Mary Hospital and Kwong Wah Hospital. Infertile patients undergoing IVF treatment will be recruited during ovarian stimulation. They will be randomly assigned to one of two groups: the microfluidic chip group or the density gradient group. Both the patients and the clinicians will be blinded to the group allocation.
The inclusion criteria for the study are infertile women aged under 43 years undergoing ovarian stimulation for IVF. The exclusion criteria include women undergoing certain genetic testing, male factor infertility requiring surgical sperm retrieval, the use of donor oocytes and spermatozoa, certain uterine conditions, previous participation in the study, and participation in other randomized trials.
The eligible women will undergo standard IVF procedures, including ovarian stimulation, monitoring of follicle growth, trigger for oocyte retrieval, and oocyte retrieval itself. On the day of oocyte retrieval, the women will be randomly assigned to either the microfluidic chip group or the density gradient group for sperm preparation.
Semen samples will be collected on the day of oocyte retrieval and evaluated according to standard guidelines. Sperm DNA damage will also be assessed using an alkaline single-cell gel electrophoresis assay. Depending on the randomization, the sperm samples will be prepared either using the microfluidic chip or the density gradient centrifugation method.
After sperm preparation, oocytes will be fertilized using either conventional insemination or intracytoplasmic sperm injection. Fertilization will be confirmed by the presence of two pronuclei. Fresh embryo transfer will be performed 2-5 days after egg retrieval, and luteal phase support will be given. Excessive good quality embryos or blastocysts will be cryopreserved for future use.
For frozen embryo transfer, embryos or blastocysts will be replaced in subsequent natural or hormonal replacement cycles. Pregnancy will be confirmed by a urine pregnancy test, and transvaginal ultrasound will be performed to confirm viability and the number of fetuses.
Follow-up will be conducted to retrieve pregnancy and delivery data. The cumulative live birth rate will be calculated, and pregnancy outcomes, including birth weights and obstetric complications, will be recorded and compared between the two groups.
The study will continue until all cryopreserved embryos or blastocysts are used or until the participants become pregnant within 6 months after randomization. The pregnancy complications and congenital abnormalities will be monitored through hospital records or patient contact.
Ultimately, the study aims to determine whether the use of the microfluidic chip improves the cumulative live birth rate of IVF compared to the density gradient method.
- Conditions
- Infertility
- Being tested
- Microfluidic chip, Density-gradient centrifugation
- Keywords
- microfluidic chip, density-gradient centrifugation, in-vitro fertilisation, sperm preparation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfluidic chipDevice
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 centrifugationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| microfluidic chip method | Experimental | 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).
In the microfluidic chip method for sperm sorting, a small amount of semen sample is loaded onto the chip, which contains channels and chambers that allow for the separation of sperm based on their motility and morphology. The chip is designed to mimic the natural environment of the female reproductive tract, where sperm undergo a series of selection processes before reaching the egg. Receives: Device: Microfluidic chip |
| density-gradient centrifugation method | Active comparator | 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. Receives: Device: Density-gradient centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative live birth rate
cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.
Measured: within 6 months of randomisation.
Secondary outcomes (7)
Live birth beyond 22 weeks of gestation per the first embryo transfer or FET
Live birth beyond 22 weeks of gestation per the first embryo transfer or FET
Measured: 3 years
Positive urine pregnancy test per the first embryo transfer or FET
Positive urine pregnancy test per the first embryo transfer or FET
Measured: 3 years
Clinical pregnancy per the first embryo transfer or FET defined as presence of intrauterine gestational sac on scanning at gestational week 6.
Clinical pregnancy per the first embryo transfer or FET defined as presence of intrauterine gestational sac on scanning at gestational week 6.
Measured: 3 years
Ongoing pregnancy rate as presence of a fetal pole with pulsation at 8-10 weeks of gestation
Ongoing pregnancy rate as presence of a fetal pole with pulsation at 8-10 weeks of gestation
Measured: 3 years
Miscarriage defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.
Miscarriage defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.
Measured: 3 years
Multiple pregnancy: presence of more than one intrauterine sac at 6 weeks of gestation
Multiple pregnancy: presence of more than one intrauterine sac at 6 weeks of gestation
Measured: 3 years
Ectopic pregnancy rate
Ectopic pregnancy rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Nov 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Ernest Hung-Yu Ng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Ernest Hung-Yu Ng, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005311
- Sponsor's protocol ID
- UW 23-293
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Lee STC, Tong PYW, Lam KKW, Lock CHY, Lam MT, Lai SF, Leung ETY, Chiu PCN, Li RHW, Yeung WSB, Ng EHY. Randomised double-blind controlled study protocol of the cumulative live birth rate of in vitro fertilisation following sperm preparation by a microfluidic chip method versus a density gradient centrifugation method. BMJ Open. 2026 Jul 3;16(7):e119056. doi: 10.1136/bmjopen-2026-119056.
PubMed 42398986
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Controlled Study of the Cumulative Live Birth Rate of IVF Following Sperm Preparation by Microfluidic Chip Method Versus Density-gradient Centrifugation Method
- ClinicalTrials.gov ID
- NCT06005311
- Acronym / sponsor ID
- UW 23-293
- Conditions
- Infertility
- Keywords
- microfluidic chip, density-gradient centrifugation, in-vitro fertilisation, sperm preparation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,136 participants (estimated)
- Lead sponsor
- Professor Ernest Hung-Yu NgUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial will compare the use of a microfluidic chip with the use of density gradient centrifugation for sperm preparation.
The hypothesis of the study is that the use of the microfluidic chip will improve the cumulative live birth rate of IVF compared to the density gradient method.
The trial will be conducted at the Centre of Assisted Reproduction and Embryology at Queen Mary Hospital and Kwong Wah Hospital. Infertile patients undergoing IVF treatment will be recruited during ovarian stimulation. They will be randomly assigned to one of two groups: the microfluidic chip group or the density gradient group. Both the patients and the clinicians will be blinded to the group allocation.
The inclusion criteria for the study are infertile women aged under 43 years undergoing ovarian stimulation for IVF. The exclusion criteria include women undergoing certain genetic testing, male factor infertility requiring surgical sperm retrieval, the use of donor oocytes and spermatozoa, certain uterine conditions, previous participation in the study, and participation in other randomized trials.
The eligible women will undergo standard IVF procedures, including ovarian stimulation, monitoring of follicle growth, trigger for oocyte retrieval, and oocyte retrieval itself. On the day of oocyte retrieval, the women will be randomly assigned to either the microfluidic chip group or the density gradient group for sperm preparation.
Semen samples will be collected on the day of oocyte retrieval and evaluated according to standard guidelines. Sperm DNA damage will also be assessed using an alkaline single-cell gel electrophoresis assay. Depending on the randomization, the sperm samples will be prepared either using the microfluidic chip or the density gradient centrifugation method.
After sperm preparation, oocytes will be fertilized using either conventional insemination or intracytoplasmic sperm injection. Fertilization will be confirmed by the presence of two pronuclei. Fresh embryo transfer will be performed 2-5 days after egg retrieval, and luteal phase support will be given. Excessive good quality embryos or blastocysts will be cryopreserved for future use.
For frozen embryo transfer, embryos or blastocysts will be replaced in subsequent natural or hormonal replacement cycles. Pregnancy will be confirmed by a urine pregnancy test, and transvaginal ultrasound will be performed to confirm viability and the number of fetuses.
Follow-up will be conducted to retrieve pregnancy and delivery data. The cumulative live birth rate will be calculated, and pregnancy outcomes, including birth weights and obstetric complications, will be recorded and compared between the two groups.
The study will continue until all cryopreserved embryos or blastocysts are used or until the participants become pregnant within 6 months after randomization. The pregnancy complications and congenital abnormalities will be monitored through hospital records or patient contact.
Ultimately, the study aims to determine whether the use of the microfluidic chip improves the cumulative live birth rate of IVF compared to the density gradient method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| microfluidic chip method | Experimental | Device: Microfluidic chipMicrofluidic 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). In the microfluidic chip method for sperm sorting, a small amount of semen sample is loaded onto the chip, which contains channels and chambers that allow for the separation of sperm based on their motility and morphology. The chip is designed to mimic the natural environment of the female reproductive tract, where sperm undergo a series of selection processes before reaching the egg. |
| density-gradient centrifugation method | Active comparator | Device: Density-gradient centrifugationDensity-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. |
Who may qualify
- Ages
- Up to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Infertile women aged <43 years at the time of ovarian stimulation for IVF
Key exclusion criteria (6 listed)
- 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;
- Women who had been recruited into this study before and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfluidic chipThe 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. | Device | microfluidic chip method |
| Density-gradient centrifugationAfter 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. | Device | density-gradient centrifugation method |
Primary outcome
cumulative live birth rate
Time frame: within 6 months of randomisation.
cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.
7 secondary outcomes
Live birth beyond 22 weeks of gestation per the first embryo transfer or FET
Time frame: 3 years
Positive urine pregnancy test per the first embryo transfer or FET
Time frame: 3 years
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
Ongoing pregnancy rate as presence of a fetal pole with pulsation at 8-10 weeks of gestation
Time frame: 3 years
Miscarriage defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.
Time frame: 3 years
Multiple pregnancy: presence of more than one intrauterine sac at 6 weeks of gestation
Time frame: 3 years
Ectopic pregnancy rate
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 42398986Lee STC, Tong PYW, Lam KKW, Lock CHY, Lam MT, Lai SF, Leung ETY, Chiu PCN, Li RHW, Yeung WSB, Ng EHY. Randomised double-blind controlled study protocol of the cumulative live birth rate of in vitro fertilisation following sperm preparation by a microfluidic chip method versus a density gradient centrifugation method. BMJ Open. 2026 Jul 3;16(7):e119056. doi: 10.1136/bmjopen-2026-119056.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfluidic chip and Density-gradient centrifugation in people with Infertility, run by Professor Ernest Hung-Yu Ng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YU WING TONG, MBBS (92707722, ptong@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative live birth rate (time frame: within 6 months of randomisation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.