Clinical trial Recruiting at 1 site Interventional Ages Any age to 43

Comparing two methods for sperm preparation in IVF

Official title: 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

Run by The University of Hong Kong · NCT06005311 · Data updated 2026-11-12

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

Study typeInterventional
AgesAny age to 43 Years
SexAll
Enrollment1136 (estimated)
SponsorThe University of Hong Kong
Academic / other
Locations1 site (Hong Kong, Hong Kong)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedNovember 30, 2027
Study endsNovember 30, 2029
Registry record updatedDecember 6, 2024
Trial IDNCT06005311 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infertile women under 43 years old who are undergoing ovarian stimulation for IVF.

Probably not a fit

Patients with male factor infertility requiring surgical sperm retrieval or those using donor gametes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Potential benefit: If successful, this study could lead to higher live birth rates for patients undergoing IVF.

How similar studies have gone: While the use of microfluidic technology in reproductive medicine is promising, this specific comparison has not been widely tested in prior studies.

Who can join: the full rules

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 it's running

  • Department of Obstetrics and Gynaecology
    Hong Kong, Hong Kong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.