Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles.
Funda Gode, Taylan Bodur, Fatma Gunturkun...
https://pubmed.ncbi.nlm.nih.gov/31543253Actively Recruiting
Phase Not Applicable
Age: 18Years - 36Years
All Genders
Healthy Volunteers
ID06144268
Evaluation of Live Birth Rate After Sperm Selection Using Microfluidic Technology (ZyMôt Multi (850µL) Sperm Separation Device) for Intra Uterine Insemination
Led by Universitair Ziekenhuis Brussel · Updated on 2024-01-30
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two sperm preparation methods for couples undergoing Intra Uterine Insemination (IUI) as a treatment for infertility, including mild male factor infertility, anovulation, endometriosis, unexplained infertility, lesbian couples, or single women using donor sperm. The study evaluates whether using the ZyMôt Multi (850µL) sperm separation device improves live birth rates compared to the standard Density Gradient Centrifugation (DGC) method. This pilot randomized controlled trial is conducted at a single center and plans to enroll couples referred for IUI with fresh autologous semen. Participants will be randomly assigned to either the standard DGC sperm preparation or the ZyMôt Multi device group. The DGC method separates sperm based on density using centrifugation steps with silica particle gradients, while the ZyMôt Multi device uses a chemical-free, microfluidic sorting process without centrifugation to select motile, morphologically normal sperm. The selected sperm are then used in up to three consecutive IUI attempts within six months, maintaining the assigned sperm preparation method throughout. During the study, couples will undergo IUI procedures using the sperm selected by their assigned method, followed by monitoring for pregnancy, clinical pregnancy, and neonatal outcomes. The primary outcome measured is the cumulative live birth rate after three IUIs within nine months. Secondary outcomes include pregnancy and miscarriage rates within specified timeframes. The study includes detailed semen processing, ultrasound monitoring of follicles and tubes, and follow-up on pregnancy outcomes.
CONDITIONS
Brief Title
Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination
Who Can Participate
Age: 18Years - 36Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Fresh autologous ejaculate
- Female age under 37 years at start of first insemination
- First IUI procedure at this center, up to 3 consecutive IUIs within 6 months
- Body mass index (BMI) less than 35
- Natural menstrual cycles or with ovulation induction allowed
- Presence of 1 or 2 follicles at last ultrasound
- Regular menstrual cycles between 26 and 35 days
- More than 1 million total progressive motile sperm count after routine capacitation with DGC
- At least one patent fallopian tube confirmed by Hyfosy
You will not qualify if you...
- Presence of intracavitary pathology detected by ultrasound
- Evidence of advanced endometriosis (Grade 3 or 4)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants undergo up to 3 consecutive intrauterine insemination (IUI) procedures using either the ZyMōt Multi (850µL) device or Density Gradient Centrifugation (DGC) sperm selection method.
Up to 3 IUI visits
Follow-up
Duration - Up to 9 months following the first IUI
Participants are monitored for pregnancy outcomes, including pregnancy confirmation, miscarriage, and live birth after the IUI procedures.
Approximately 3 visits for pregnancy assessment and monitoring
Trial Site Locations
Total: 1 location
1
UZ Brussel CRG
Brussels, Belgium, 1090
Actively Recruiting
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Research Team
E
Elsie Nulens
I
Ileana Mateizel, PhD
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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