Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age (IVF)
Evaluation of the Effectiveness of Live Motile Sperm Sorting Device on In Vitro Fertilization Outcomes in Advanced Paternal Age Group
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Male infertility contributes to approximately 50% of all infertility cases. One of the essential steps in assisted reproductive technology (ART) is sperm preparation, which aims to select motile, morphologically normal spermatozoa with minimal DNA damage. However, conventional sperm preparation techniques involving centrifugation may increase oxidative stress and sperm DNA fragmentation. The live motile sperm sorting device LensHooke® CA0 has been proposed as an alternative to traditional density gradient centrifugation (DGC), aiming to reduce sperm damage and potentially improve IVF outcomes.
LensHooke® CA0 offers several advantages: it avoids centrifugation and the mechanical stress associated with it; optimally reduces the DNA fragmentation index (DFI); minimizes the risk of premature acrosome reaction (AR); is suitable for both normozoospermic and non-normozoospermic semen samples; simplifies workflow (only three pipetting steps required: loading, medium addition, and recovery); and ensures a high degree of standardization, reducing inter-technician variability.
Moreover, paternal age is an important factor influencing sperm quality and fertility potential. Studies have demonstrated that men over 40 years of age exhibit higher sperm DNA fragmentation rates, increased morphological and motility abnormalities, and are associated with a higher incidence of embryonic chromosomal abnormalities and reduced live birth rates. Therefore, this population particularly requires optimized sperm selection methods to improve IVF/ICSI outcomes.
This study aims to evaluate the clinical value of this device through two primary objectives:
- To compare sperm quality post-processing and the DNA fragmentation index between the CA0 method and the conventional DGC method in advanced paternal age group.
- To compare the rates of blastocyst formation, euploid embryos, and clinical pregnancy between the two sperm preparation techniques in advanced paternal age group.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Son The Trinh
- Número de teléfono: + 84 902150873
- Correo electrónico: trinhtheson@vmmu.edu.vn
Ubicaciones de estudio
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Ha Dong
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Hà Nội, Ha Dong, Vietnam, 100000
- Reclutamiento
- Vietnam Military medical university
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Contacto:
- Phuong Minh Nguyen, M.D
- Número de teléfono: 0963048428
- Correo electrónico: nguyenminhphuongk53@vmmu.edu.vn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male partners aged ≥ 40 years
- Semen analysis: volume ≥ 1.4 mL, sperm concentration ≥ 6 million/mL, progressive motility (PR) ≥ 20% after 3-5 days of abstinence.
- Female partners with ≥ 5 mature (MII) oocytes retrieved.
- Couples undergoing ICSI with PGT-A and elective single embryo transfer (eSET).
- Willingness to participate and sign informed consent.
Exclusion Criteria:
- Azoospermia, surgical sperm retrieval, or use of cryopreserved sperm.
- Female uterine or ovarian conditions severely affecting IVF outcomes.
- Use of donor sperm or donor oocytes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Study group (CA0)
Sperm preparation using LensHooke® CA0 live motile sperm sorting device.
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Sperm will be processed using the CA0 device by loading 1.0 mL of semen into the lower chamber and adding 0.9 mL of pre-equilibrated sperm washing medium into the upper chamber. The device is incubated at 37 °C for a minimum of 30 minutes, followed by aspirating 0.5 mL of recovered sperm suspension for ICSI. |
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Comparador activo: Control group (DGC)
Conventional sperm preparation using density gradient centrifugation.
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Sperm will be prepared by layering 1 mL of 45% medium and 1 mL of 90% medium with 1 mL of semen sample. This is followed by a first centrifugation at 1500 rpm for 15 minutes, a wash step using 2 mL G-IVF plus medium, and a second centrifugation at 1200 rpm for 10 minutes to retain 0.5 mL of the sperm suspension. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Pregnancy Rate after single embryo transfer
Periodo de tiempo: 4 to 6 weeks after embryo transfer
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Confirmed by the presence of an intrauterine gestational sac on ultrasound.
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4 to 6 weeks after embryo transfer
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-processing sperm DNA fragmentation index (DFI, %)
Periodo de tiempo: Immediately after sperm preparation on the day of oocyte retrieval
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Evaluated using the LensHooke® R11 Plus assay
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Immediately after sperm preparation on the day of oocyte retrieval
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Blastocyst rate and good-quality blastocysts rate
Periodo de tiempo: Day 5 to Day 6 after ICSI
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Evaluated according to Gardner's criteria and classified following Munné et al. (2019)
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Day 5 to Day 6 after ICSI
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Euploidy rate.
Periodo de tiempo: Within 2 weeks after blastocyst biopsy
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Assessed via preimplantation genetic testing for aneuploidy (PGT-A) using next-generation sequencing (NGS).
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Within 2 weeks after blastocyst biopsy
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MICEH-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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