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
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
Treatments tested in this trial
- ZyMōt Multi (850µL)
- Density Gradient Centrifugation
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov