Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment

South Valley University

Status: Enrolling

Conditions: Teratozoospermia

Treatments: Drug: l-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT07016867

Isolated Teratozoospermia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 3 patient groups

Group of l-carnitine and antioxidant

Active Comparator group

Description:

About 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months

Treatment:

Drug: l-carnitine

Group of varicocelectomy

Active Comparator group

Description:

About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy.

Treatment:

Drug: l-carnitine

Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant)

Active Comparator group

Description:

About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months.

Treatment:

Drug: l-carnitine