None listed
Conditions
Brief summary
The purpose of this study is to evaluate how effective the ZYMOT® device is in enhancing sperm selection before fertilisation. ZYMOT® device, commonly used in IVF to prepare and select sperm cells for fertilisation, relies on the sperm’s natural swimming ability to help select the best sperm cells for either IVF or Intracytoplasmic sperm injection (ICSI) fertilisation. Embryo development arrest at the cleavage stages of embryo development may be due to suboptimal sperm quality. We aim to assess the benefits of ZYMOT® for couples who have had a previous IVF cycle marked by a low number of viable embryos.
Interventions
The intervention will be sperm selection using microfluidic sperm selection (with Zymot device) prior to fertilisation with In Vitro Fertilisation / ICSI (In vitro fertilisation / Intracytoplasmic sperm).
The ZYMOT device: The ZYMOT microfluidic sperm selection device separates motile, morphologically normal sperm with lower DNA fragmentation using parallel laminar flow channels. Selected sperm are collected from the outlet channel for fertilisation via IVF or ICSI depending on semen paramete
The intervention will be sperm selection using microfluidic sperm selection (with Zymot device) prior to fertilisation with In Vitro Fertilisation / ICSI (In vitro fertilisation / Intracytoplasmic sperm). The ZYMOT device: The ZYMOT microfluidic sperm selection device separates motile, morphologically normal sperm with lower DNA fragmentation using parallel laminar flow channels. Selected sperm are collected from the outlet channel for fertilisation via IVF or ICSI depending on semen parameters. Procedures, activities, and processes: 1. Semen sample collected after recommended abstinence period (2–5 days). 2. Sample loaded into ZYMOT device. 3. Laminar flow separates motile sperm from debris and immotile sperm. 4. Selected sperm collected from outlet. 5. Sperm used for fertilisation (IVF or ICSI), with oocytes divided equally between intervention and control groups. 6. Embryos cultured and monitored as per standard protocols. After oocyte collection, the eggs are split equally: one half undergoes standard sperm preparation and fertilisation, and the other half is fertilised using ZYMOT microfluidic sperm selection. -Inject 3 eggs with Zymot prepared sperm, then 3 eggs with Puresperm prepared sperm, continue this alternating pattern, ensuring an equal split. - For the next case - inject 3 eggs with Puresperm prepared sperm, then 3 eggs with Zymot prepared sperm, continue the alternating pattern, ensuring an equal split. Personnel delivering the intervention: The procedure is performed by the study group embryologist. Duration: Sperm preparation is performed on Day 0 (day of oocyte collection) and typically takes 30–60 minutes, consistent with standard sperm preparation procedures. Location and setting: RSU laboratory at the Royal Women’s Hospital (RWH), Melbourne, an accredited ART facility. Adherence strategies: • Direct observation of all procedures by the study embryologist. • Documentation in laboratory records and CRFs. • Regular oversight and audit according to Good Clinical Practice (GCP).
Sponsors
The Royal Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
23 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Couples who had a previous IVF cycle with utilisation rate of less than 25%, which is 1 standard deviation below our unit’s average utilisation rate, and are planned for another IVF cycle, i.e study stimulation cycle.
Exclusion criteria
Couples with less than 6 oocytes collected during the study stimulation cycle - Female age > 40 - Severe azoospermia of less than 1 million/ml - Patients who are planned for testicular sperm extraction - Sperm or eggs donation
Outcome results
None listed