RecruitingACTRN12625001229460

Assessing the efficacy of microfluidic sperm selection in couples with low embryo utilisation rate

Sponsor

The Royal Women's Hospital

Enrollment

92 participants

Start Date

Nov 25, 2024

Study Type

Interventional

Conditions

Fertility Low embryo utilisation (poor quality) rate

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.

Eligibility

Sex: Both males and femalesMin Age: 23 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

When couples undergo IVF (in vitro fertilisation), one factor that affects success is the quality of the sperm used to fertilise the eggs. Poor sperm quality can lead to embryos that stop developing early. This study is testing a device called the ZYMOT, which selects sperm cells based on their natural swimming ability — a technique that may favour sperm with less DNA damage. The study is specifically for couples who had a previous IVF cycle where fewer than 25% of fertilised eggs became usable embryos (a low utilisation rate), as this may indicate a sperm quality issue. In their next IVF cycle, the ZYMOT device will be used for sperm selection and outcomes compared to their previous cycle. You may be eligible if you are a couple planning a further IVF cycle after a previous cycle with a low embryo utilisation rate (under 25%), and the female partner is under 40. Couples where fewer than 6 eggs were collected in the current cycle, where sperm are being surgically retrieved, or where donor sperm or eggs are being used are not eligible.

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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 sp

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).