Actively Recruiting
Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination
Led by Universitair Ziekenhuis Brussel · Updated on 2024-01-30
240
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fresh autologous ejaculate
- Female age under 37 years at start of first insemination
- First IUI at this center, with up to 3 consecutive IUIs within 6 months
- Body mass index (BMI) less than 35
- Natural menstrual cycles or ovulation induction allowed
- Presence of 1 or 2 follicles on last ultrasound
- Regular menstrual cycles every 26 to 35 days
- Total Progressive Motile Sperm Count (TPMC) over 1 million after routine capacitation with DGC
- At least one functional fallopian tube confirmed by Hyfosy
You will not qualify if you...
- Presence of intracavitary pathology seen on ultrasound
- Diagnosis of advanced endometriosis (Grade 3 or 4)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UZ Brussel CRG
Brussels, Belgium, 1090
Actively Recruiting
Research Team
E
Elsie Nulens
CONTACT
I
Ileana Mateizel, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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