Status:
COMPLETED
Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF
Lead Sponsor:
Fundación IVI
Conditions:
Oligospermia
DNA Damage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In patients with oligospermia in the ejaculate or previous ICSI failures if it concurs with high DNA fragmentation, it has been hypothesized that the use of sperm obtained from the testicle would impr...
Detailed Description
Since its first description in 1992, intracytoplasmic sperm injection (ICSI) has been widely used to overcome all forms of severe male factor infertility. Despite achieving acceptable success rates wi...
Eligibility Criteria
Inclusion
- Infertile males with severe oligospermia (\<5 mill/ml of spermatozoa in the ejaculate) or infertile males without severe oligospermia (\>5 mill/ml of spermatozoa in the ejaculate) but with a previous complete ICSI failure. In addition, all of them have to have a sperm DNA fragmentation test level higher than 30% (SDF\>30%), the threshold value for considering the result as abnormal.
- Women with adequate ovarian reserve, understood as those with AMH values \>10pM, and Antral Follicular Count (AFC) \>10.
Exclusion
- Abnormal karyotype (previously known).
- Microdeletions in the Y chromosome (previously known).
- Carriers of known cystic fibrosis gene mutations.
- Presence of varicocele.
- Female age \>38 years.
- Presence of uterine pathology that may condition reproductive outcomes (fibroids, uterine malformations).
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04795440
Start Date
October 1 2020
End Date
October 30 2023
Last Update
March 13 2025
Active Locations (1)
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1
IVI Foundation
Valencia, Valencia, Spain, 46026