TeratozoospermiaNCT07016867
Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment
A study testing l-carnitine in people with Teratozoospermia, run by South Valley University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Teratozoospermia
- What is being tested?
- l-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).
- Men with teratozoospermia.
Who cannot join
- Recurrent varicoceles.
- Significant medical diseases as: Hepatic insufficiency.
- Hypersensitivity to the drugs.
- Female factor of infertility.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Valley University Hospital
Qina, South Valley
Omar Mohamed El-Saghier, Assist.Prof, +201095421734, Omarelsoqier1983@yahoo.com
Atef Fathi Ali, Assist.Prof, +201111380109, ateffathi2010@yahoo.com
About this study
Official title: Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study
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.
Read the 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.
- Conditions
- Teratozoospermia
- Being tested
- l-carnitine
- Medical subject headings
- Teratozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
l-carnitineDrug
Also called Antioxidants, varicocelectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Group of l-carnitine and antioxidant | Active comparator | About 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months Receives: Drug: l-carnitine |
| Group of varicocelectomy | Active comparator | About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy. Receives: Drug: l-carnitine |
| Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant) | Active comparator | About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months. Receives: Drug: l-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Sep 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeratozoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Mohamed Ali, South Valley University
- Investigators
- Mohammad Sayed Abdel-Kader, Professor, Study chair, Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016867
- Sponsor's protocol ID
- Isolated Teratozoospermia
- Status last verified
- Sep 2024
- First submitted
- 28 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07016867
- Acronym / sponsor ID
- Isolated Teratozoospermia
- Conditions
- Teratozoospermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group of l-carnitine and antioxidant | Active comparator | Drug: l-carnitineAbout 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months |
| Group of varicocelectomy | Active comparator | Drug: l-carnitineAbout 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy. |
| Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant) | Active comparator | Drug: l-carnitineAbout 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).
- Men with teratozoospermia.
Key exclusion criteria (4 listed)
- Recurrent varicoceles.
- Significant medical diseases as: Hepatic insufficiency.
- Hypersensitivity to the drugs.
- Female factor of infertility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| l-carnitineAlso: Antioxidants, varicocelectomyto 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. | Drug | Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant), Group of l-carnitine and antioxidant, Group of varicocelectomy |
Primary outcome
Number of participants with Treatment of Teratozoospermia
Time frame: 3 months
Treatment of the male patients that suffering from abnormally shaped sperms (Teratozoospermia) by medical treatment and or subinguinal varicocelcetomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Sayed Abdel-Kader, Professor study chair
Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing l-carnitine in people with Teratozoospermia, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwan Mohamed Ali Bastawy, Resident (+201066067330, marwan13156@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment of Teratozoospermia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.