AsthenozoospermiaNCT05436080
Epididymal U.S Findings in Asthenozoospermic &Correlation With L.Carnitine Level
An observational study of Asthenozoospermia, run by Assiut University.
Trial summary
To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- U/S
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to Dec 2024
- Phase
- Observational
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Study participants: Patients will be chosen from those attending the outpatient clinic of department of Dermatology, Venereology and Andrology, Assuit University hospitals
Who may be able to join
- 80 married male( 50 asthenzoospermic infertile male and 30 with normal semen male) Age from 18 to 55 years.
Who cannot join
- Extreme age
- Single
- Recent L carnitine intake
- Undesended testis
- Genetic cause of inferitility
- Patients with clinical Varicocele
- Azoospermic patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epididymal Ultrasongraphic Findings in Asthenozoospermic Infertile Men and Correlation With Seminal Parameters and L.Carnitine Level
To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males
Read the detailed description
infertility is a relatively common problem affecting about15-20% of reproductive aged couples. Historically, the cause of infertility was falsified attributed to the female partner, while the male factor, which is either primary or a co factor in 40-60% of cases, has largely been ignored Thus, it is important to evaluate men at the same time with women.(2) The epididymis is an elongated structure, posterolateral to the testis within the scrotal sac. Its primary function is the collection, maturation and transport of sperm from rete testis to the ductus deferens.(1)(3) Testicular spermatozoa are nonfunctional and lack the ability to naturally fertilize an oocyte .After, spermatozoa reach the epididymis they undergo a complicated maturation process leading to biochemical, physiological and functional changes resulting in a functional spermatozo on that is able to successfully fertilize an oocyte (3)(4)(8) Sperm dysfunctions are recognised as the most significant cause of male infertility and many may think that sperm dysfunction is only as a result of defective spermatogenesis. However, it can also be the result of an inadequate epididymal maturation process due to improper epididymal function (6)(7)(8) Scrotal sonography is commonly used for evaluation of the infertile male. While abnormalities of the epididymis like( cysts and calcifications ) are frequently observed during sonographic assessment and their presence has uncertain importance (1)(10)(12)(13) Measurement of acetyl carnitine content of human seminal plasma could be used as a marker of epididymal maturation. Carnitine is present in the epididymis at higher concentrations than in other body tissues in the rat
- Conditions
- Asthenozoospermia
- Being tested
- U/S
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U/SDevice
Epididymal Ultrasongraphic Findings by Scrotal U/S
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level
The sample size calculation was performed using G.power 3.1.9.2 (Universitat Kiel, Germany). The sample size was calculated as total n ≥65 with an allocation ratio of 5:3 in cases and control groups based on the following considerations: 0.05 α error and 80% power of the study to demonstrate that the percentage of epididymal head echotexture heterogeneity is 60% in infertile men (the primary outcome) compared to 25% in healthy fertile men according to a previous study by (Lotti et al., 2021). 15 cases were added to overcome dropout. Therefore, 80 patients will be allocated as 30 cases in fertile group and 50 cases in infertile group.
Lotti, F., Frizza, F., Balercia, G., Barbonetti, A., Behre, H. M., Calogero, A. E., et al. 2021. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology, 9, 559-576
Measured: Baseline
Secondary outcomes (1)
Evaluate other epididymal ultrasongraphic findings and study its correlation with seminal parameters and L.carnitine level
Evaluate other epididymal ultrasongraphic findings like( vascularity ,cyst, volume) and study its correlation with seminal parameters and L.carnitine level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Aug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthenozoospermiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Abo Elyamen, Assiut University
- Investigators
- Emad abdel rahiem taha, Study director, Assiut UniversityAhmed mahmoud el shibany, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436080
- Sponsor's protocol ID
- epididymal findindgs by u.s
- Status last verified
- Aug 2023
- First submitted
- 23 Jun 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lotti F, Frizza F, Balercia G, Barbonetti A, Behre HM, Calogero AE, Cremers JF, Francavilla F, Isidori AM, Kliesch S, La Vignera S, Lenzi A, Marcou M, Pilatz A, Poolamets O, Punab M, Peraza Godoy MF, Rajmil O, Salvio G, Shaeer O, Weidner W, Maseroli E, Cipriani S, Baldi E, Degl'Innocenti S, Danza G, Caldini AL, Terreni A, Boni L, Krausz C, Maggi M. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology. 2021 Mar;9(2):559-576. doi: 10.1111/andr.12951. Epub 2021 Jan 19.
PubMed 33244893
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epididymal Ultrasongraphic Findings in Asthenozoospermic Infertile Men and Correlation With Seminal Parameters and L.Carnitine Level
- ClinicalTrials.gov ID
- NCT05436080
- Acronym / sponsor ID
- epididymal findindgs by u.s
- Conditions
- Asthenozoospermia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jun 2022 (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.
To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males
Detailed description
infertility is a relatively common problem affecting about15-20% of reproductive aged couples. Historically, the cause of infertility was falsified attributed to the female partner, while the male factor, which is either primary or a co factor in 40-60% of cases, has largely been ignored Thus, it is important to evaluate men at the same time with women.(2) The epididymis is an elongated structure, posterolateral to the testis within the scrotal sac. Its primary function is the collection, maturation and transport of sperm from rete testis to the ductus deferens.(1)(3) Testicular spermatozoa are nonfunctional and lack the ability to naturally fertilize an oocyte .After, spermatozoa reach the epididymis they undergo a complicated maturation process leading to biochemical, physiological and functional changes resulting in a functional spermatozo on that is able to successfully fertilize an oocyte (3)(4)(8) Sperm dysfunctions are recognised as the most significant cause of male infertility and many may think that sperm dysfunction is only as a result of defective spermatogenesis. However, it can also be the result of an inadequate epididymal maturation process due to improper epididymal function (6)(7)(8) Scrotal sonography is commonly used for evaluation of the infertile male. While abnormalities of the epididymis like( cysts and calcifications ) are frequently observed during sonographic assessment and their presence has uncertain importance (1)(10)(12)(13) Measurement of acetyl carnitine content of human seminal plasma could be used as a marker of epididymal maturation. Carnitine is present in the epididymis at higher concentrations than in other body tissues in the rat
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study participants: Patients will be chosen from those attending the outpatient clinic of department of Dermatology, Venereology and Andrology, Assuit University hospitals
Key inclusion criteria (1 listed)
- 80 married male( 50 asthenzoospermic infertile male and 30 with normal semen male) Age from 18 to 55 years.
Key exclusion criteria (7 listed)
- Extreme age
- Single
- Recent L carnitine intake
- Undesended testis
- Genetic cause of inferitility
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 |
|---|---|---|
| U/SEpididymal Ultrasongraphic Findings by Scrotal U/S | Device | – |
Primary outcome
Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level
Time frame: Baseline
The sample size calculation was performed using G.power 3.1.9.2 (Universitat Kiel, Germany). The sample size was calculated as total n ≥65 with an allocation ratio of 5:3 in cases and control groups based on the following considerations: 0.05 α error and 80% power of the study to demonstrate that the percentage of epididymal head echotexture heterogeneity is 60% in infertile men (the primary outcome) compared to 25% in healthy fertile men according to a previous study by (Lotti et al., 2021). 15 cases were added to overcome dropout. Therefore, 80 patients will be allocated as 30 cases in fertile group and 50 cases in infertile group. Lotti, F., Frizza, F., Balercia, G., Barbonetti, A., Behre, H. M., Calogero, A. E., et al. 2021. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology, 9, 559-576
1 secondary outcome
Evaluate other epididymal ultrasongraphic findings and study its correlation with seminal parameters and L.carnitine level
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 33244893Lotti F, Frizza F, Balercia G, Barbonetti A, Behre HM, Calogero AE, Cremers JF, Francavilla F, Isidori AM, Kliesch S, La Vignera S, Lenzi A, Marcou M, Pilatz A, Poolamets O, Punab M, Peraza Godoy MF, Rajmil O, Salvio G, Shaeer O, Weidner W, Maseroli E, Cipriani S, Baldi E, Degl'Innocenti S, Danza G, Caldini AL, Terreni A, Boni L, Krausz C, Maggi M. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology. 2021 Mar;9(2):559-576. doi: 10.1111/andr.12951. Epub 2021 Jan 19.
Related trials for Asthenozoospermia
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Recruiting
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
Male Infertility, Oxidative Stress
Recruiting
Probiotics on Sperm Quality in Male Infertility Patients
Male Infertility, Oligozoospermia
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.
Emad abdel rahiem taha study director
Assiut University
Ahmed mahmoud el shibany study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Asthenozoospermia, run by Assiut University.
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 1 inclusion and 7 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 yasser mohamed (01555509202, taher2014mohamed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436080, which also lists 1 linked publication.
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 16 Aug 2023.