Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment

NCT ID: NCT07016867

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Teratozoospermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group of l-carnitine and antioxidant

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

Group Type ACTIVE_COMPARATOR

l-carnitine

Intervention Type DRUG

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.

Group of varicocelectomy

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

Group Type ACTIVE_COMPARATOR

l-carnitine

Intervention Type DRUG

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.

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

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

Group Type ACTIVE_COMPARATOR

l-carnitine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Antioxidants varicocelectomy

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Marwan Mohamed Ali

Resident of Urology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad Sayed Abdel-Kader, Professor

Role: STUDY_CHAIR

Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt

Locations

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South Valley University Hospital

Qina, South Valley, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwan Mohamed Ali Bastawy, Resident

Role: CONTACT

+201066067330

Facility Contacts

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Omar Mohamed El-Saghier, Assist.Prof

Role: primary

+201095421734

Atef Fathi Ali, Assist.Prof

Role: backup

+201111380109

Other Identifiers

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Isolated Teratozoospermia

Identifier Type: -

Identifier Source: org_study_id

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