Medicine alone, surgery, or both for varicocele-related teratozoospermia
Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study
This trial will test whether taking L-carnitine, having varicocele surgery, or combining both helps men with teratozoospermia improve sperm shape and chances of conceiving.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Male |
| Sponsor | South Valley University Academic / other |
| Locations | 1 site (Qina, South Valley) |
| Trial ID | NCT07016867 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares three approaches for subfertile men with clinically palpable varicoceles and abnormal sperm morphology: medical treatment with L-carnitine, microsurgical varicocelectomy, or the combination of both. Diagnosis is based on physical examination of the scrotum, and the surgical arm uses the microsurgical subinguinal technique commonly used for varicocele repair. Outcomes will focus on changes in semen parameters, especially sperm morphology, and downstream fertility indicators such as conception or assisted reproduction outcomes. The study also considers the role of oxidative stress and antioxidant therapy as a lower-risk alternative or adjunct to surgery.
Who should consider this trial
Good fit: Ideal candidates are subfertile men with clinically palpable unilateral or bilateral varicoceles and teratozoospermia who do not have significant medical illness and whose partners do not have a female infertility factor.
Not a fit: Men with recurrent varicoceles, significant medical conditions such as hepatic insufficiency, hypersensitivity to the drug, or couples with a primary female infertility factor are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could identify whether L-carnitine alone or combined with surgery improves sperm morphology and fertility, potentially offering a less invasive option or an effective combined strategy for affected men.
How similar studies have performed: Prior studies consistently show surgical varicocelectomy improves semen parameters, while antioxidant therapies like L-carnitine have shown variable but promising results in smaller trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Qina, South Valley
- South Valley University Hospital — Qina, South Valley, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwan Mohamed Ali Bastawy, Resident
- Email: marwan13156@gmail.com
- Phone: +201066067330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.