Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment

Not Applicable

Recruiting

• Conditions: Teratozoospermia
• Interventions: Drug: l-carnitine

• Registration Number: NCT07016867
• Lead Sponsor: South Valley University

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.

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-08-20
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 126

Inclusion Criteria

• Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).
• Men with teratozoospermia.

Exclusion Criteria

• Recurrent varicoceles.
• Significant medical diseases as: Hepatic insufficiency.
• Hypersensitivity to the drugs.
• Female factor of infertility.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of l-carnitine and antioxidant	l-carnitine	About 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months
Group of varicocelectomy	l-carnitine	About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy.
Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant)	l-carnitine	About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months.

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment of Teratozoospermia	3 months	Treatment of the male patients that suffering from abnormally shaped sperms (Teratozoospermia) by medical treatment and or subinguinal varicocelcetomy

Trial Locations

Locations (1)

South Valley University Hospital; 🇪🇬 Qinā, South Valley, Egypt