Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF (NCT07004309) | Clinical Trial Compass
CompletedNot Applicable
Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF
Vietnam119 participantsStarted 2023-03-14
Plain-language summary
This randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (DGC) in reducing sperm DNA fragmentation index (DFI) and improving clinical outcomes in IVF. A total of 119 couples underwent IVF and were assigned to either microfluidic or DGC sperm preparation. The study evaluated sperm quality, fertilization, embryo development, and live birth rates.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female partner aged between 18 and 40 years
* Couples undergoing in vitro fertilization (IVF) cycles at the IVF and Tissue Engineering Center, Hanoi Medical University, between January 2022 and January 2024
* Use of autologous oocytes
* Use of ejaculated sperm
* Both partners provide written informed consent
Exclusion Criteria:
* Use of donor oocytes or donor sperm
* Requirement for testicular sperm extraction
* Diagnosis of oligoasthenozoospermia (OA) based on WHO 2021 criteria
* Female partner classified as having poor ovarian prognosis according to the POSEIDON 2016 criteria, including:
* Anti-Müllerian hormone (AMH) level \< 1.2 ng/mL
* Antral follicle count (AFC) \< 5
* Or history of poor ovarian response (≤9 oocytes retrieved in previous cycles)
* Preimplantation genetic testing (PGT) cycles
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.