Comparing two methods for sperm preparation in IVF
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
This study is testing whether a new sperm preparation method using a microfluidic chip can help infertile women under 43 have more successful pregnancies through IVF compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1136 (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 | NCT06005311 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness of a microfluidic chip method against a density-gradient centrifugation method for sperm preparation in infertile patients undergoing in-vitro fertilization (IVF). Infertile women under 43 years old will be randomly assigned to one of the two groups during ovarian stimulation for IVF at Queen Mary Hospital and Kwong Wah Hospital. The primary outcome measured will be the cumulative live birth rate within six months of randomization, with both patients and clinicians blinded to group allocation. The study seeks to determine if the microfluidic chip can improve live birth rates compared to the traditional method.
Who should consider this trial
Good fit: Ideal candidates are infertile women under 43 years old who are undergoing ovarian stimulation for IVF.
Not a fit: Patients with male factor infertility requiring surgical sperm retrieval or those using donor gametes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to higher live birth rates for patients undergoing IVF.
How similar studies have performed: While the use of microfluidic technology in reproductive medicine is promising, this specific comparison has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infertile women aged \<43 years at the time of ovarian stimulation for IVF Exclusion Criteria: * 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
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.