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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brussels, , Belgium
Patients applied
Trial Officials
Shari Mackens, MD, PhD
Principal Investigator
Universitair Ziekenhuis Brussel
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported