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Search / Trial NCT06144268

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

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Nov 16, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Intra Uterine Insemination Live Birth Microfluidic Sperm Selection

ClinConnect Summary

This clinical trial is studying two different methods for preparing sperm to see which one helps couples achieve a live birth during a procedure called Intra Uterine Insemination (IUI). One method is the standard approach called Density Gradient Centrifugation, while the other uses a new device called the ZyMōt Multi. The goal is to find out if using the ZyMōt device leads to a higher number of live births compared to the standard method.

To participate in this trial, women must be under 37 years old and having their first IUI, with a maximum of three IUI attempts over six months. They also need a certain number of healthy sperm and must not have certain health issues, such as severe endometriosis. If eligible, participants can expect to be randomly assigned to one of the two sperm preparation methods and will help researchers learn more about fertility treatments. This study is currently recruiting participants, and it's important for couples to discuss this opportunity with their healthcare provider to see if it might be right for them.

Gender

ALL

Eligibility criteria

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

About Universitair Ziekenhuis Brussel

Universitair Ziekenhuis Brussel (UZ Brussel) is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution affiliated with the Vrije Universiteit Brussel, UZ Brussel integrates cutting-edge medical research with high-quality patient care. The hospital's multidisciplinary teams are dedicated to exploring novel therapeutic approaches and contributing to the development of evidence-based treatments, ensuring the highest standards of safety and efficacy in clinical research. With a strong focus on collaboration and knowledge dissemination, UZ Brussel plays a pivotal role in shaping the future of medicine and improving patient outcomes.

Locations

Brussels, , Belgium

Patients applied

0 patients applied

Trial Officials

Shari Mackens, MD, PhD

Principal Investigator

Universitair Ziekenhuis Brussel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported