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Microfluidic Sperm Selection Versus Density Gradient Centrifugation in ICSI Cycles With Abnormal Semen Parameters: A Randomized Sibling-Oocyte Study

Microfluidic Sperm Selection Versus Density Gradient Centrifugation in ICSI Cycles With Abnormal Semen Parameters: A Randomized Sibling-Oocyte Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250130004
Enrollment
55
Registered
2025-01-30
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Couples undergoing ICSI treatment Male partner with at least one abnormal semen parameter based on WHO 2021 criteria Microfluidic sperm selection density gradient centrifugation intracytoplasmic sperm injection abnormal semen parameters sibling-oocyte study embryo development

Interventions

Sibling metaphase II oocytes allocated to this arm undergo ICSI using sperm prepared by microfluidic sperm selection.,Sibling metaphase II oocytes allocated to this arm undergo ICSI using sperm prepar
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Microfluidic sperm selection,Density gradient centrifugation (DGC)

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Couples undergoing ICSI treatment Male partner with at least one abnormal semen parameter based on WHO 2021 criteria Female age less than 42 years More than 4 dominant follicles on trigger day

Exclusion criteria

Exclusion criteria: Participants with fewer than 4 retrieved oocytes (MII) Sperm volume less than 1.4 ml on the date of oocyte retrieval Pre-preparation TMSC <5 million participants with limited decision-making capacity

Design outcomes

Primary

MeasureTime frame
Blastocyst formation Rate day 5-6 after ICSI embryo development assessment by embryologist

Secondary

MeasureTime frame
fertilization rate day 1 after ICSI embryo development assessment by embryologist,Cleavage rate day 3 after ICSI embryo development assessment by embryologist,Euploidy rate after blastocyst biopsy and PGT-A result reporting PGT-A by NGS,good-quality blastocyst rate Day 5-6 after ICSI embryo development assessment by embryologist

Countries

Thailand

Contacts

Public ContactChatsaran Thanapongpibul

Faculty of Medicine Ramathibodi Hospital, Mahidol University

chatsaran.tha@mahidol.ac.th0645850846

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026