Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedJune 12, 2025
September 1, 2024
12 months
May 28, 2025
June 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with Treatment of Teratozoospermia
Treatment of the male patients that suffering from abnormally shaped sperms (Teratozoospermia) by medical treatment and or subinguinal varicocelcetomy
3 months
Study Arms (3)
Group of l-carnitine and antioxidant
ACTIVE COMPARATORAbout 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months
Group of varicocelectomy
ACTIVE COMPARATORAbout 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy.
Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant)
ACTIVE COMPARATORAbout 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).
- Men with teratozoospermia.
You may not qualify if:
- Recurrent varicoceles.
- Significant medical diseases as: Hepatic insufficiency.
- Hypersensitivity to the drugs.
- Female factor of infertility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Valley University Hospital
Qina, South Valley, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohammad Sayed Abdel-Kader, Professor
Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of Urology, Faculty of Medicine
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 12, 2025
Study Start
September 1, 2024
Primary Completion
August 20, 2025
Study Completion
August 31, 2025
Last Updated
June 12, 2025
Record last verified: 2024-09