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Effect of Different Sperm Processing Methods in ICSI Outcome.

Effect of Different Sperm Processing Methods ( Swim up, Zeta, Sperm Gradient Centrifugation ) in ICSI Outcome. A Sperm DNA Perspective

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03668106
Enrollment
20
Registered
2018-09-12
Start date
2018-05-01
Completion date
2022-07-01
Last updated
2022-09-21

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

Conditions

Sperm DNA Fragmentation

Brief summary

A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up, sperm gradient centrifugation and Zeta methods. SDF and ICSI outcomes are monitored after semen processing.

Detailed description

A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up (G1/ n=40), sperm gradient centrifugation (G2/ n=40) and Zeta (G3/ n=40) methods. SDF test was assessed by Halosperm kit, whereas sperm morphology was assessed by spermac stain according to strict criteria. Fertilization, division, blastulation, implantation and pregnancy rates will be tabulated and statistically tested.

Interventions

PROCEDUREsperm processing method

different sperm processing method for selcting most proper sperm for ICSI

Sponsors

Hawaa Fertility Center
CollaboratorOTHER
Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

zeta technique

Intervention model description

swim up technique

Eligibility

Sex/Gender
ALL
Age
20 Years to 37 Years
Healthy volunteers
No

Inclusion criteria

* unexplained infertile couples for 2 years * age from 20 years old to 37 years old

Exclusion criteria

* endometriosis cases * uterine factors

Design outcomes

Primary

MeasureTime frameDescription
Sperm DNA fragmentation30 minutesmeasure sperm integrity by halosperm assay

Secondary

MeasureTime frameDescription
Oocyte fertilization rateday 1no. of oocytes fertilized /total no. of oocytes
Blastulation rateday 5no of embryos blastulated / total no. of embryos
pregnancy rate15 daysno of pregnant cases\\ all no. of cases

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026