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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-36
SponsorUniversitair Ziekenhuis Brussel

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ZyMōt Multi (850µL)

    Device

    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.

  • Density Gradient Centrifugation

    Other intervention

    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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Density Gradient Centrifugation (DGC)Active comparator 1 intervention
Group B: ZyMōt Multi (850µL)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative live birth rate after 3 consecutive IUIs

Number of live births per number of inseminations

Time frame
9 months following IUI

Secondary outcomes

1

Pregnancy rate

number of pregnancies (positive hCG) per number of inseminations

Time frame
14 days following IUI
2

Miscarriages rate

number of miscarriages per number of inseminations

Time frame
12 weeks following IUI

Other outcomes

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