Comparing sperm selection methods for intrauterine insemination
Official title: Evaluation of Live Birth Rate After Sperm Selection Using Microfluidic Technology (ZyMōt Multi (850µL) Sperm Separation Device) for Intra Uterine Insemination.
Run by Universitair Ziekenhuis Brussel · NCT06144268 · Data updated 2026-11-12
This study is testing two different ways to prepare sperm for couples trying to get pregnant through intrauterine insemination to see which method leads to more successful pregnancies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 36 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | January 10, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | January 30, 2024 |
| Trial ID | NCT06144268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women under 37 years old with mild infertility issues and a sufficient sperm count for IUI.
✕Probably not a fit
Patients with advanced endometriosis or significant intracavitary pathology 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 pilot randomized control study aims to evaluate the effectiveness of two sperm preparation methods for couples undergoing intrauterine insemination (IUI). Participants will be randomly assigned to either the standard Density Gradient Centrifugation (DGC) method or the ZyMōt Multi (850µL) device. The primary outcome will be the live birth rate following the IUI procedures, assessing which method yields better results in terms of successful pregnancies. The study focuses on couples facing various infertility issues, including mild male factor infertility and unexplained infertility.
Why it matters
Potential benefit: If successful, this study could improve live birth rates for couples undergoing IUI by identifying a more effective sperm selection method.
How similar studies have gone: Previous studies have shown varying success with different sperm selection techniques, but this specific comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fresh autologous ejaculate * Female age: \<37 at start of the first insemination * 1st IUI ever here, maximum 3 consecutive IUIs during max 6 months * BMI \<35 * All natural cycles, ovulation induction allowed * Presence of 1 or 2 follicles at the last ultrasound * Regular menses (26-35 days) * \>1 million Total Progressive Motile Sperm Count (TPMC) after previous routine capacitation with DGC * Presence of at least 1 potent tube after Hyfosy Exclusion Criteria: * Presence of intracavitary pathology at ultrasound * Evidence of advance endometriosis (Grade 3 and 4)
Where it's running
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UZ Brussel CRG
Brussels, Belgium Recruiting
Study contacts
- Principal investigator: Shari Mackens, MD, PhD — Universitair Ziekenhuis Brussel
- Study coordinator: Elsie Nulens
- Email: elsie.nulens@uzbrussel.be
- Phone: 0032 2 4742676
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.