Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination
Evaluation of Live Birth Rate After Sperm Selection Using Microfluidic Technology (ZyMōt Multi (850µL) Sperm Separation Device) for Intra Uterine Insemination.
Universitair Ziekenhuis Brussel
240 participants
Jan 10, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- Fresh autologous ejaculate
- Female age: <37 at start of the first insemination
- st 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 Criteria2
- Presence of intracavitary pathology at ultrasound
- Evidence of advance endometriosis (Grade 3 and 4)
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Interventions
An amount of 850 µl untreated semen sample will be loaded into the inlet chamber with a help of a sterile insulin-type syringe. A volume of 750 µl of Sage Quinn's AdvantageTM Medium with Hepes + 5% HSA-solution medium will be placed on top of the membrane (outlet chamber). After 30 min of incubation in a humidified incubator (37°C), 500 µl of medium, containing the selected spermatozoa, will be retrieved from the upper side of the membrane (retrieval chamber). An amount of 400 µl will be necessary for the IUI procedure.
The gradient columns will be prepared by placing 1 ml 80% gradient media in a centrifuge tube and an additional 1 ml of 40% gradient layered on top. The raw semen sample will be placed on top of the gradient (1ml semen/gradient tube) and centrifuged at 300xg for 20 minutes. The sperm pellet will be collected and washed 2 times for 5 min at 800xg in Sage Quinn's AdvantageTM Medium with Hepes + 5% HSA-solution. The resulted pellet will be resuspended in the washing solution in a volume that will provide at least 1x106 forward motile spermatozoa in 400 µl, as this amount is necessary for IUI procedure.
Locations(1)
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NCT06144268