Status:
COMPLETED
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Lead Sponsor:
Ganin Fertility Center
Conditions:
Male Infertility
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.
Detailed Description
Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rat...
Eligibility Criteria
Inclusion
- Male partner with abnormal sperm DNA fragmentation index (\>20%) by TUNEL assay
- Male partner with at least 1 million progressive motile count
- Male aged 18-50 years
- Male with adjusted sexual abstinence days (1-2 days)
- Female aged 18-37 years
- Normo-responder females (at least 5 mature oocytes)
Exclusion
- Leukocytospermia
- Varicocele
- Known genetic abnormality
- Use of oocyte or sperm donors
- Use of a gestational carrier
- Presence of any endometrial factors that can affect embryo implantation
- Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04496232
Start Date
August 1 2020
End Date
December 1 2021
Last Update
August 9 2022
Active Locations (1)
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1
Ganin Fertility Center
Cairo, Cairo Governorate, Egypt, 11728