Comparing sperm selection methods for intrauterine insemination
Evaluation of Live Birth Rate After Sperm Selection Using Microfluidic Technology (ZyMōt Multi (850µL) Sperm Separation Device) for Intra Uterine Insemination.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 36 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06144268 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women under 37 years old with mild infertility issues and a sufficient sperm count for IUI.
Not a fit: Patients with advanced endometriosis or significant intracavitary pathology may not benefit from this study.
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 performed: Previous studies have shown varying success with different sperm selection techniques, but this specific comparison is relatively novel.
Eligibility criteria
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 this trial is running
Brussels
- 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
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.