Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing

NCT06023472 | Recruiting FDA Device

• 1 other identifier: UW 23-297
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility; Genetic Disease; Chromosomal Rearrangement; Aneuploidy

Keywords

microfluidic chip; density gradient centrifugation; euploidy rate; pre-implantation genetic testing

Outcome Measures

Primary Outcomes (1)

• Euploid rate of blastocysts

  Euploid rate of blastocysts biopsied

  3 months

Secondary Outcomes (8)

• Live birth rate of the first embryo transfer

  3 years

• Positive urine pregnancy test rate per the first embryo transfer

  3 years

• Clinical pregnancy rate of the first embryo transfer

  3 years

• Ongoing pregnancy rate

  3 years

• Miscarriage rate pregnancy

  3 years

Study Arms (2)

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.

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.

Device: density gradient centrifugation

Interventions

microfluidic chip DEVICE

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).

The microfluidic chip group

density gradient centrifugation DEVICE

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.

The density gradient centrifugation group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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; Genetic Diseases, Inborn; Aneuploidy

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: 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 The women and clinicians will be blinded to the treatment groups they are assigned. Only the laboratory staff in the IVF laboratory performing sperm preparation will be aware of the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: September 5, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• 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)