Microfluidic Chip Method Versus Density-gradient Centrifugation Method in IVF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microfluidic chip, Density-gradient centrifugation.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: up to 43 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Microfluidic chip
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 pipette - Device Density-gradient centrifugation
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.
Primary outcome measures
- cumulative live birth rate [Time frame: within 6 months of randomisation.]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- Infertile women aged <43 years at the time of ovarian stimulation for IVF
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Obstetrics and Gynaecology — Hong Kong
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. PMID 42398986
Identifiers
NCT: NCT06005311 · UW 23-293