NCT06144268 Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination
| NCT ID | NCT06144268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2024-01-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This single centre interventional pilot randomized control study intends to compare two methods of sperm preparation for couples referred for Intra Uterine Insemination (IUI) procedure. Couples will be randomly allocated to one of the two sperm selection methods: Density Gradient Centrifugation (DGC, standard) or ZyMōt Multi (850µL) device (treatment) groups. The study will compare the live birth rate (number of live births per number of IUI procedures) between the treatment and standard groups.
Eligibility 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)
Contact & Investigator
Shari Mackens, MD, PhD
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT06144268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 36 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06144268 currently recruiting?
Yes, NCT06144268 is actively recruiting participants. Contact the research team at elsie.nulens@uzbrussel.be for enrollment information.
Where is the NCT06144268 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06144268 clinical trial?
NCT06144268 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Shari Mackens, MD, PhD at Universitair Ziekenhuis Brussel. The trial plans to enroll 240 participants.