Comparing two methods for sperm preparation in IVF
A Randomized Comparison of Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing
This study is testing which of two sperm preparation methods helps improve the chances of having healthy embryos for couples undergoing IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | N/A to 43 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT06023472 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two sperm preparation methods, microfluidic chip and density gradient centrifugation, in improving the euploidy rate during pre-implantation genetic testing (PGT) for couples undergoing in vitro fertilization (IVF). Infertile women will be recruited and randomly assigned to one of the two groups during their IVF treatment. The study will maintain blinding for both participants and clinicians to ensure unbiased results. The primary goal is to determine which method yields better outcomes in terms of genetic viability of embryos.
Who should consider this trial
Good fit: Ideal candidates are women under 43 years old undergoing PGT for genetic conditions or chromosomal issues.
Not a fit: Patients using frozen sperm or donor gametes, or those with untreated reproductive abnormalities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the success rates of IVF by improving embryo quality through better sperm preparation techniques.
How similar studies have performed: Previous studies have shown varying success with different sperm preparation techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hong Kong, Hong Kong
- Department of Obstetrics and Gynaecology — Hong Kong, Hong Kong, China (Recruiting)
Study contacts
- Study coordinator: Yu Wing Tong, Mbbs
- Email: ptong@connect.hku.hk
- Phone: 92707722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.