About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Presence of intracavitary pathology at ultrasound
Evidence of advance endometriosis (Grade 3 and 4)
Trial design
Parallel
Treatments tested in this trial
ZyMōt Multi (850µL)
DeviceAn 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.
Density Gradient Centrifugation
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Cumulative live birth rate after 3 consecutive IUIs
Number of live births per number of inseminations
Secondary outcomes
Pregnancy rate
number of pregnancies (positive hCG) per number of inseminations
Miscarriages rate
number of miscarriages per number of inseminations
Sponsors and contacts
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