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Recruiting NCT07016867

Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment

No phase Interventional Teratozoospermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: l-carnitine.
Who it may be relevant to
Registry conditions: Teratozoospermia. Basic parameters: 20 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study

Overview

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.

Interventions

  • Drug l-carnitine
    to compare the efficacy of medical treatment (l-carnitine and antioxidants) versus surgical treatment (varicocelectomy) versus surgical treatment and medical treatment (varicocelectomy with adjuvant medications) on pregnancy rate on varicocele related subfertility patients with isolated teratozoospermia.

Primary outcome measures

  • Number of participants with Treatment of Teratozoospermia [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • South Valley University Hospital — Qina

Identifiers

NCT: NCT07016867 · Isolated Teratozoospermia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗