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

Recruiting now · Not applicable

Conditions studied: Infertility, Fertility Disorders

In brief

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.

Key facts

Study ID

NCT06144268

Run by

Universitair Ziekenhuis Brussel

People needed

240

Starts

2024-01-10

Expected to finish

2027-12-01

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older, up to 36. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• Presence of intracavitary pathology at ultrasound
• Evidence of advance endometriosis (Grade 3 and 4)

Where it is running

• UZ Brussel CRG — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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