Male InfertilityNCT06257459
Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy
A study testing subinguinal varicocelectomy in people with Male Infertility, run by Tanta University at 1 site in Egypt.
Trial summary
In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- subinguinal varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Dec 2024
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult infertile males
- Clinical varicocele
- Semen analysis show oligo-athenospermia
Who cannot join
- Adolescent varicocele
- Recurrent varicocele
- Presence of inguinal hernia
- Azospermic patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Zoeir
Tanta, Gharbia Governorate, 11511
Ahmed Zoeir, +201008634198, drahmedzoeir27@gmail.com
About this study
Official title: Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy in Infertile Men With Oligo-asthenzoospermia: A Prospective Randomized Trial.
In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery
Read the detailed description
This will be a prospective randomized study, in which adult infertile patients with clinical varicocele and oligo-athenospermia admitted to Urology department Tanta university hospital will be included and then the patients with detected spermatic cord lipoma at the time surgery will be enrolled and divided into 2 groups:
GROUP A : will undergo subinguinal varicocelectomy with excision of spermatic cord lipoma GROUP B : will undergo subinguinal varicocelectomy with preservation of spermatic cord lipoma
Inclusion criteria:
- Adult infertile males
- Clinical varicocele
- oligo-asthenospermia
Exclusion criteria:
- Adolescent varicocele
- Recurrent varicocele
- Presence of inguinal hernia
- Azospermic patients
- Conditions
- Male Infertility
- Being tested
- subinguinal varicocelectomy
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subinguinal varicocelectomyProcedure or surgery
exision or preservation of spermatic cord lipoma during subinguinal varicocelectomy
| Study group | Role | What they receive |
|---|---|---|
| Lipoma Excision (group A) | Active comparator | excison of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males Receives: Procedure: subinguinal varicocelectomy |
| Lipoma Preservation (group B) | Active comparator | preservation of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males Receives: Procedure: subinguinal varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
semen parameters improvement
semen analysis
Measured: 3 and 6 months after surgery
symptoms improvement (pain and swelling)
improvement of preoperative scrotal pain and swelling was assessed
Measured: 3 and 6 months after surgery
Secondary outcomes (1)
postoperative complications
post-operative scrotal edema, hematoma and wound infection were assessed
Measured: early after surgery and late
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zoeir, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257459
- Sponsor's protocol ID
- 36137/12/22
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy in Infertile Men With Oligo-asthenzoospermia: A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT06257459
- Acronym / sponsor ID
- 36137/12/22
- Conditions
- Male Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Feb 2024 (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.
In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery
Detailed description
This will be a prospective randomized study, in which adult infertile patients with clinical varicocele and oligo-athenospermia admitted to Urology department Tanta university hospital will be included and then the patients with detected spermatic cord lipoma at the time surgery will be enrolled and divided into 2 groups:
GROUP A : will undergo subinguinal varicocelectomy with excision of spermatic cord lipoma GROUP B : will undergo subinguinal varicocelectomy with preservation of spermatic cord lipoma
Inclusion criteria:
- Adult infertile males
- Clinical varicocele
- oligo-asthenospermia
Exclusion criteria:
- Adolescent varicocele
- Recurrent varicocele
- Presence of inguinal hernia
- Azospermic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipoma Excision (group A) | Active comparator | Procedure: subinguinal varicocelectomyexcison of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males |
| Lipoma Preservation (group B) | Active comparator | Procedure: subinguinal varicocelectomypreservation of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult infertile males
- Clinical varicocele
- Semen analysis show oligo-athenospermia
Key exclusion criteria (4 listed)
- Adolescent varicocele
- Recurrent varicocele
- Presence of inguinal hernia
- Azospermic patients
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 |
|---|---|---|
| subinguinal varicocelectomyexision or preservation of spermatic cord lipoma during subinguinal varicocelectomy | Procedure or surgery | Lipoma Excision (group A), Lipoma Preservation (group B) |
Primary outcome
semen parameters improvement
Time frame: 3 and 6 months after surgery
semen analysis
symptoms improvement (pain and swelling)
Time frame: 3 and 6 months after surgery
improvement of preoperative scrotal pain and swelling was assessed
1 secondary outcome
postoperative complications
Time frame: early after surgery and late
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subinguinal varicocelectomy in people with Male Infertility, run by Tanta 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 3 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 14 Feb 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semen parameters improvement (time frame: 3 and 6 months after surgery). The study lists 2 primary outcomes in all. 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 14 Feb 2024.