Effect of Different Sperm Processing Methods in ICSI Outcome.

Sperm DNA Fragmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03668106
• Other study ID #: Hawaa-4
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: May 1, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 1, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 37 Years

Eligibility

Inclusion Criteria:

• unexplained infertile couples for 2 years

• age from 20 years old to 37 years old

Exclusion Criteria:

• endometriosis cases

• uterine factors

Related Conditions & MeSH terms

• Sperm DNA Fragmentation

Intervention

Procedure:
• sperm processing method
different sperm processing method for selcting most proper sperm for ICSI

Locations

Country	Name	City	State
Egypt	Ahmed Saad	Banha	Qalubiya

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm DNA fragmentation	measure sperm integrity by halosperm assay	30 minutes
Secondary	Oocyte fertilization rate	no. of oocytes fertilized /total no. of oocytes	day 1
Secondary	Blastulation rate	no of embryos blastulated / total no. of embryos	day 5
Secondary	pregnancy rate	no of pregnant cases\ all no. of cases	15 days