Actively Recruiting
A Randomized Comparison of Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
Led by Professor Ernest Hung-Yu Ng · Updated on 2024-12-06
318
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates two sperm preparation methods used during in vitro fertilization (IVF) for infertile women undergoing preimplantation genetic testing (PGT). The study aims to compare the microfluidic chip method and density gradient centrifugation to evaluate their effects on the euploidy rate of embryos and other IVF outcomes such as pregnancy rates and obstetric complications. Eligible couples will be recruited during ovarian stimulation for IVF, and randomization will take place on the day of oocyte retrieval in a double-blind manner. Participants will be assigned to either the microfluidic chip group, where sperm will be prepared using a specialized device following the manufacturer's instructions, or the density gradient centrifugation group, where sperm will be separated using a gradient centrifugation method and washed before fertilization. Women will undergo ovarian stimulation using injections and monitoring, followed by oocyte retrieval. Fertilization is performed via intracytoplasmic sperm injection using the prepared sperm samples. Embryos will be tested genetically, and only chromosomally normal blastocysts will be used for frozen embryo transfer in subsequent cycles. During the study, semen samples will be collected and evaluated for quality and DNA damage. Pregnancy outcomes will be tracked through urine tests and ultrasounds, with detailed data collected on pregnancy progress, delivery, birth weights, and any complications. The primary outcome measured is the euploid rate of blastocysts within three months, and secondary outcomes include live birth rates and pregnancy outcomes over three years. Participants will be closely monitored throughout the IVF process and follow-up periods.
CONDITIONS
Brief Title
Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged under 43 years at the time of ovarian stimulation for IVF
- Women undergoing preimplantation genetic testing for monogenic diseases, chromosomal structural rearrangement, or aneuploidy
- Raw semen sperm concentration with at least 0.15 million motile sperm per ml or 100 motile sperm per 50 low power field (200x)
You will not qualify if you...
- Use of frozen semen for insemination
- Use of donor oocytes and spermatozoa
- Presence of submucosal fibroid or hydrosalpinx on pelvic scan not surgically treated
- Women previously recruited into this study
- Women participating in other randomized trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 6 weeks
Participants undergo ovarian stimulation with gonadotropin injections, followed by sperm preparation using either the microfluidic chip or density gradient centrifugation method. Oocytes are fertilized via intracytoplasmic sperm injection and blastocysts are biopsied and cryopreserved.
Weekly visits for ovarian stimulation monitoring, 1 visit for oocyte retrieval and sperm collection
Duration - 1 to 2 months
Participants have euploid blastocysts transferred in subsequent natural or hormonal replacement cycles based on menstrual regularity.
1 to 2 visits depending on menstrual cycle scheduling
Duration - Up to 3 years
Pregnancy outcomes are monitored through urine pregnancy tests and transvaginal ultrasounds, followed by collection of delivery and obstetric data.
Several visits for pregnancy tests and ultrasounds during early pregnancy, additional follow-up after delivery
Trial Site Locations
Total: 1 location
1
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Actively Recruiting
Research Team
Y
YU WING TONG, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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