InfertilityNCT06023472
Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
A study testing microfluidic chip and density gradient centrifugation in people with Infertility and Genetic Disease, run by Professor Ernest Hung-Yu Ng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 43 years
- Conditions the study is for
- Infertility, Genetic Disease, Chromosomal Rearrangement
- 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
- 318 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Nov 2028
- 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
- 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
Who cannot join
- 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
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 Comparison of Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
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.
Read the detailed description
The study aims to investigate the treatment of couples undergoing in vitro fertilization (IVF). Eligible couples will be recruited for the study after providing informed written consent following counseling. The IVF protocol involves various steps. Women will undergo preimplantation genetic testing (PGT) as clinically indicated. Ovarian stimulation will be carried out using gonadotropin injections, and regular ultrasound monitoring will be conducted to track the growth of follicles. To prevent a premature LH surge, progestin primed ovarian stimulation or a GnRH antagonist will be administered. Once at least three follicles reach a size of over 17 mm, a trigger injection of either human chorionic gonadotrophin or a GnRH agonist will be given to induce final maturation. Oocyte retrieval will be performed 36 hours after the trigger under transvaginal ultrasound guidance.
The recruited women will be randomly assigned to one of two groups: the microfluidic chip group or the density gradient centrifugation group. Randomization and blinding will be ensured to maintain the integrity of the study. Only the laboratory staff involved in sperm preparation will be aware of the group assignment, while the women and clinicians will be blinded to the treatment groups.
Semen specimens will be collected by masturbation on the day of oocyte retrieval, following a period of 2-7 days of sexual abstinence. The semen samples will undergo evaluation according to WHO guidelines, including semen volume, sperm concentration, and percent motile spermatozoa. Sperm DNA damage will be assessed using an alkaline single-cell gel electrophoresis (Comet) assay. The extent of DNA damage in spermatozoa will be examined using specific parameters.
Sperm preparation will be performed based on the randomization list. In the microfluidic chip group, the Sperm Separation Device will be used, and the prepared sample will be collected in a test tube. In the density gradient centrifugation group, sperm preparation will be completed using a discontinuous density gradient centrifugation method, and the resulting sperm pellet will be washed and resuspended.
Oocytes will be fertilized through intracytoplasmic sperm injection, and normal fertilization will be confirmed by the presence of two pronuclei. A few cells will be taken from the blastocysts for comprehensive chromosome analysis. Cryopreservation of all blastocysts will be done, and only euploid blastocysts without aneuploidies will be replaced in subsequent frozen embryo transfer cycles.
Frozen embryo transfer (FET) will be performed in subsequent natural or hormonal replacement cycles, depending on the women's menstrual cycle regularity.
Pregnancy outcomes will be monitored through urine pregnancy tests and transvaginal ultrasounds. If the pregnancy test is positive, further ultrasounds will be done to confirm fetal viability and the number of fetuses. Pregnancy and delivery data will be retrieved after delivery, and information on pregnancy outcomes, number of babies born, birth weights, and obstetric complications will be recorded.
The study aims to assess the effectiveness of the two different sperm preparation methods and their impact on IVF outcomes, including pregnancy rates and obstetric complications.
- Conditions
- Infertility, Genetic Disease, Chromosomal Rearrangement, Aneuploidy
- Being tested
- microfluidic chip, density gradient centrifugation
- Keywords
- microfluidic chip, density gradient centrifugation, euploidy rate, pre-implantation genetic testing
- Medical subject headings
- Infertility, Genetic Diseases, Inborn, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microfluidic chipDevice
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 centrifugationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The microfluidic chip group | Experimental | The Sperm Separation Device - ZyMōt Multi 850µL or 3 mL device (ZyMōt Fertility, Inc) will be used according to the volume of the raw semen samples. The microfluidics chamber will be used based on the manufacturer's instructions. 850 μL (850 μL device) or 3 mL (3mL device) of the semen sample will be added to the inlet port of the device and 750 μL (850 μL device) or 2.4 mL (3 mL device) of fertilization media will be added to the outlet port. The device will then be incubated in 6% CO2 at 37°C. After 30 minutes, 500 μL (850 μL device) or 1 mL (3mL device) of the prepared sample at the outlet port will be removed and pipetted into a labelled test tube. Receives: Device: microfluidic chip |
| The density gradient centrifugation group | Active comparator | 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. Receives: Device: density gradient centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploid rate of blastocysts
Euploid rate of blastocysts biopsied
Measured: 3 months
Secondary outcomes (8)
Live birth rate of the first embryo transfer
No. of live birth beyond 22 weeks of gestation per the first embryo transfer
Measured: 3 years
Positive urine pregnancy test rate per the first embryo transfer
No. of positive urine pregnancy test per the first embryo transfer
Measured: 3 years
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.
Measured: 3 years
Ongoing pregnancy rate
No. of ongoing pregnancy as presence of a fetal pole with pulsation at 8-10 weeks of gestation
Measured: 3 years
Miscarriage rate pregnancy
No. of 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 rate
Multiple pregnancy rate: presence of more than one intrauterine sac at 6 weeks of gestation
Measured: 3 years
DNA fragmentation
Measurement of DNA fragmentation by Comet assay using the Olive tail moment as the quantitative metric.
Measured: 3 years
Ectopic pregnancy rate
No. of ectopic pregnancy
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 posted5 Sep 2023
- Study start1 Nov 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- On the day of oocyte retrieval, recruited women will be randomly assigned into one of the following two groups according to a computer-generated randomization list with a 1:1 ratio and a block size of 10. The randomization list will be prepared by a designated research nurse who is not involved in care of the women and opened by a laboratory staff. 1. The microfluidic chip group and 2. The density gradient centrifugation group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 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
- NCT06023472
- Sponsor's protocol ID
- UW 23-297
- 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
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 Comparison of Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
- ClinicalTrials.gov ID
- NCT06023472
- Acronym / sponsor ID
- UW 23-297
- Conditions
- Infertility, Genetic Disease, Chromosomal Rearrangement, Aneuploidy
- Keywords
- microfluidic chip, density gradient centrifugation, euploidy rate, pre-implantation genetic testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 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 2028 (estimated)
- First posted
- 5 Sep 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 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.
Detailed description
The study aims to investigate the treatment of couples undergoing in vitro fertilization (IVF). Eligible couples will be recruited for the study after providing informed written consent following counseling. The IVF protocol involves various steps. Women will undergo preimplantation genetic testing (PGT) as clinically indicated. Ovarian stimulation will be carried out using gonadotropin injections, and regular ultrasound monitoring will be conducted to track the growth of follicles. To prevent a premature LH surge, progestin primed ovarian stimulation or a GnRH antagonist will be administered. Once at least three follicles reach a size of over 17 mm, a trigger injection of either human chorionic gonadotrophin or a GnRH agonist will be given to induce final maturation. Oocyte retrieval will be performed 36 hours after the trigger under transvaginal ultrasound guidance.
The recruited women will be randomly assigned to one of two groups: the microfluidic chip group or the density gradient centrifugation group. Randomization and blinding will be ensured to maintain the integrity of the study. Only the laboratory staff involved in sperm preparation will be aware of the group assignment, while the women and clinicians will be blinded to the treatment groups.
Semen specimens will be collected by masturbation on the day of oocyte retrieval, following a period of 2-7 days of sexual abstinence. The semen samples will undergo evaluation according to WHO guidelines, including semen volume, sperm concentration, and percent motile spermatozoa. Sperm DNA damage will be assessed using an alkaline single-cell gel electrophoresis (Comet) assay. The extent of DNA damage in spermatozoa will be examined using specific parameters.
Sperm preparation will be performed based on the randomization list. In the microfluidic chip group, the Sperm Separation Device will be used, and the prepared sample will be collected in a test tube. In the density gradient centrifugation group, sperm preparation will be completed using a discontinuous density gradient centrifugation method, and the resulting sperm pellet will be washed and resuspended.
Oocytes will be fertilized through intracytoplasmic sperm injection, and normal fertilization will be confirmed by the presence of two pronuclei. A few cells will be taken from the blastocysts for comprehensive chromosome analysis. Cryopreservation of all blastocysts will be done, and only euploid blastocysts without aneuploidies will be replaced in subsequent frozen embryo transfer cycles.
Frozen embryo transfer (FET) will be performed in subsequent natural or hormonal replacement cycles, depending on the women's menstrual cycle regularity.
Pregnancy outcomes will be monitored through urine pregnancy tests and transvaginal ultrasounds. If the pregnancy test is positive, further ultrasounds will be done to confirm fetal viability and the number of fetuses. Pregnancy and delivery data will be retrieved after delivery, and information on pregnancy outcomes, number of babies born, birth weights, and obstetric complications will be recorded.
The study aims to assess the effectiveness of the two different sperm preparation methods and their impact on IVF outcomes, including pregnancy rates and obstetric complications.
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
- On the day of oocyte retrieval, recruited women will be randomly assigned into one of the following two groups according to a computer-generated randomization list with a 1:1 ratio and a block size of 10. The randomization list will be prepared by a designated research nurse who is not involved in care of the women and opened by a laboratory staff. 1. The microfluidic chip group and 2. The density gradient centrifugation group
| Arm | Type | Receives |
|---|---|---|
| The microfluidic chip group | Experimental | Device: microfluidic chipThe Sperm Separation Device - ZyMōt Multi 850µL or 3 mL device (ZyMōt Fertility, Inc) will be used according to the volume of the raw semen samples. The microfluidics chamber will be used based on the manufacturer's instructions. 850 μL (850 μL device) or 3 mL (3mL device) of the semen sample will be added to the inlet port of the device and 750 μL (850 μL device) or 2.4 mL (3 mL device) of fertilization media will be added to the outlet port. The device will then be incubated in 6% CO2 at 37°C. After 30 minutes, 500 μL (850 μL device) or 1 mL (3mL device) of the prepared sample at the outlet port will be removed and pipetted into a labelled test tube. |
| The density gradient centrifugation group | Active comparator | Device: 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. |
Who may qualify
- Ages
- Up to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 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). | Device | The microfluidic chip group |
| 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. | Device | The density gradient centrifugation group |
Primary outcome
Euploid rate of blastocysts
Time frame: 3 months
Euploid rate of blastocysts biopsied
8 secondary outcomes
Live birth rate of the first embryo transfer
Time frame: 3 years
Positive urine pregnancy test rate per the first embryo transfer
Time frame: 3 years
Clinical pregnancy rate of the first embryo transfer
Time frame: 3 years
Ongoing pregnancy rate
Time frame: 3 years
Miscarriage rate pregnancy
Time frame: 3 years
Multiple pregnancy rate
Time frame: 3 years
DNA fragmentation
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.
- 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 and Genetic Disease, 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 3 inclusion and 5 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?
Euploid rate of blastocysts (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.