Evaluation of Live Birth Rate After Sperm Selection Using Microfluidic Technology (ZyMōt Multi (850µL) Sperm Separation Device) for Intra Uterine Insemination.

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 36
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Belgium
UZ Brussel CRG
RECRUITING
Brussels
Contact Information
Primary
Elsie Nulens
elsie.nulens@uzbrussel.be
0032 2 4742676
Backup
Ileana Mateizel, PhD
ileana.mateizel@uzbrussel.be
0032 24749119
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 240
Treatments
Active_comparator: Density Gradient Centrifugation (DGC)
During this procedure, raw semen sample is placed on 2 gradients: a lower phase (80%) and an upper phase (40%) followed by centrifugation. The composition of the gradients include a colloidal suspension of silica particles. At the end of centrifugation, each spermatozoa is situated at the gradient level that matches its density. The highly motile, morphologically normal, viable spermatozoa form a pellet at the bottom of the tube.
Experimental: ZyMōt Multi (850µL)
ZyMōt Multi (850µL) is a flow-free dual chambered single-use device. The first chamber contains a sample inlet and a fluid channel separated from the second collection chamber by an 8-μm microporous membrane. Channel dimension and membrane porosity are designed to optimize the sorting and collection of the most motile sperm. Sorting is accomplished by the passage of sperm through the micropores of the membrane. This procedure does not require any preliminary semen processing, all centrifugation steps being eliminated.
Related Therapeutic Areas
Sponsors
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov