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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Son The Trinh
- Telefoonnummer: + 84 902150873
- E-mail: trinhtheson@vmmu.edu.vn
Studie Locaties
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Ha Dong
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Hà Nội, Ha Dong, Vietnam, 100000
- Werving
- Vietnam Military medical university
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Contact:
- Phuong Minh Nguyen, M.D
- Telefoonnummer: 0963048428
- E-mail: nguyenminhphuongk53@vmmu.edu.vn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical Pregnancy Rate after single embryo transfer
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-processing sperm DNA fragmentation index (DFI, %)
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MICEH-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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