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Recruiting NCT06144268

Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination

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Trial Parameters

Condition Infertility
Sponsor Universitair Ziekenhuis Brussel
Study Type INTERVENTIONAL
Phase N/A
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age 36 Years
Start Date 2024-01-10
Completion 2026-12
Interventions
ZyMōt Multi (850µL)Density Gradient Centrifugation

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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)

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