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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 43
Healthy Volunteers: f
View:

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

Locations
Other Locations
China
Department of Obstetrics and Gynaecology
RECRUITING
Hong Kong
Contact Information
Primary
YU WING TONG, MBBS
ptong@connect.hku.hk
92707722
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 1136
Treatments
Experimental: microfluidic chip method
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.
Active_comparator: density-gradient centrifugation method
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.
Related Therapeutic Areas
Sponsors
Leads: Professor Ernest Hung-Yu Ng

This content was sourced from clinicaltrials.gov