Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-18 @ 8:03 AM
Study NCT ID:
NCT07016867
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment
Sponsor:
South Valley University
Organization:
Study Overview
Official Title:
Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A varicocele is defined as an abnormal venous dilatation and/or tortuosity of the pampiniform plexus in the scrotum. Although varicoceles are almost always and more common on the left side, up to 50% of the men with varicocele, have bilateral varicoceles.
Varicocele has a negative impact on spermatogenesis, testicular volume, Standard semen parameters, and fertilization, implantation, and embryo outcomes.
Varicocele has a negative impact on spermatogenesis, testicular volume, Standard semen parameters, and fertilization, implantation, and embryo outcomes.
Detailed Description:
Varicocelectomy remains the first-line treatment option in infertile men with palpable varicocele and abnormal semen parameters, with the microsurgical subinguinal approach conveying the greatest success rate and fewest complications. The empirical use of antioxidant supplement may confer some benefits in men to reduce oxidative damage.
Medical management, including antioxidants, could offer a potential solution with lower risks given the increasing evidence suggesting the role of oxidative stress in varicocele-induced infertility.
Physical examination of the scrotum remains the most commonly used technique to diagnose varicoceles. Palpation of the scrotum is best performed in a relaxed patient in standing position, in a warm room and carried out by a well-trained physician.
Surgical treatment of varicocele has a significant effect on semen parameters, so it is considered the 'gold standard' treatment for subfertile males with palpable varicoceles associated with abnormal semen analysis.
Medical management, including antioxidants, could offer a potential solution with lower risks given the increasing evidence suggesting the role of oxidative stress in varicocele-induced infertility.
Physical examination of the scrotum remains the most commonly used technique to diagnose varicoceles. Palpation of the scrotum is best performed in a relaxed patient in standing position, in a warm room and carried out by a well-trained physician.
Surgical treatment of varicocele has a significant effect on semen parameters, so it is considered the 'gold standard' treatment for subfertile males with palpable varicoceles associated with abnormal semen analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: