Microfluidic Chip Method Versus Density-gradient Centrifugation Method in IVF

NCT06005311 | Recruiting FDA Device

• 1 other identifier: UW 23-293
• Study Type: interventional
• Target: 1,136
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility

Keywords

microfluidic chip; density-gradient centrifugation; in-vitro fertilisation; sperm preparation

Outcome Measures

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.

  within 6 months of randomisation.

Secondary Outcomes (7)

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

  3 years

• Positive urine pregnancy test per the first embryo transfer or FET

  3 years

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

  3 years

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

  3 years

• Miscarriage defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.

  3 years

Study Arms (2)

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.

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.

Device: Density-gradient centrifugation

Interventions

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.

microfluidic chip method

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.

density-gradient centrifugation method

Eligibility Criteria

• Age: Up to 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Ernest Hung-Yu Ng: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultracentrifugation; Centrifugation; Investigative Techniques; Chemistry Techniques, Analytical

Central Study Contacts

YU WING TONG, MBBS

CONTACT

92707722; ptong@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patients and clinicians were blinded from the group allocation i.e. a double blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 22, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2029
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after publication of the primary paper
• Access Criteria: reasonable request

Locations

CN (1)