Unexplained InfertilityNCT06491251
Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
A study testing Bilateral Subinguinal microscopic varicocelectomy in people with Unexplained Infertility, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Bilateral Subinguinal microscopic varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Feb 2023to 1 Aug 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients unable to conceive after 12 month of regular and unprotected intercourse
- Male patients aged 18 -45 years old
- Normal semen analysis (concentration, motility and morphology) according to WHO criteria 2021
- Infertile men with clinical varicocele (grade II,III) subjected to varicocelectomy
- No history of other congenital or acquired urogenital diseases
- Primary infertility
- Normal BMI (18.5-24..9)
Who cannot join
- History of other congenital or acquired urogenital diseases
- Age outside inclusion criteria
- Grade I varicocele confirmed by ultrasound ( subclinical varicocele )
- Abnormal semen analysis
- Recurrent varicocele
- Patient unable or unwilling to comply with follow-up schedule
- Female fertility issues (anovulation , hormonal infertility, tubal factor, endometriosis)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, 33516
Ahmed A. Khalifa, MCs, 00201016183850, Ahmed.med_0571@med.kfs.edu.eg
About this study
Official title: Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .
Read the detailed description
Infertility is defined as the absence of a desired pregnancy following regular, unprotected sexual intercourse for a period of at least 1 year. Over 15% of married couples worldwide experience fertility problems, and 50% of these cases are caused by male factor infertility.
Varicocele is the abnormal enlargement of the veins within the pampiniform plexus. The condition affects approximately 15% of the overall adult male population and 35% of men with primary infertility. Among men with secondary infertility, varicose veins are found in up to 80% of patients.
Only about 20% of all men with varicocele present with infertility. But overall, it is the most frequent abnormality found in infertile men.
Microsurgical varicocelectomy has gradually become the preferred surgical option for varicocele due to its advantages of less surgical damage, lower postoperative recurrence rate, fewer complications, higher postoperative semen quality, and higher postoperative fertility rate.
The two approaches to microsurgical varicocelectomy include the inguinal or subinguinal routes. The subinguinal approach involves the shallow spermatic cord and simple anatomic layers; it does not require the dissection of the external abdominal oblique muscle and allows for the application of spinal anesthesia.
Sub-inguinal approach assisted by microscope magnification is a safe, simple , and effective method for the treatment of sub fertile men and permit significant improvement in DNA fragmentation index and sperm parameters.
Varicocele is linked to male infertility through various nonmanually exclusive mechanisms, including an increase in the production of reactive oxygen species (ROS) that may lead to sperm deoxyribonucleic acid (DNA) damage.
Excessive sperm DNA breaks, so-called sperm DNA fragmentation (SDF), are commonly found in the ejaculates of men with varicocele and fertility-related issues. Although elevated SDF is mainly observed in men with abnormal semen parameters, namely, count, motility, and morphology, it can coexist with normozoospermia.
Semen analysis is the most important test for evaluating male infertility, but it does not provide information regarding all functions of sperm, nor is it sufficient for predicting male fertility potential and the likelihood of success of assisted reproductive technology (ART).
Furthermore, the standards for normal values in semen analysis do not reflect average values, In fact, 15% of patients with male infertility were found to have normal semen analysis results. Therefore, additional tests should be performed due to the limitations of using semen analysis results alone to evaluate male fertility potential.
Sperm DNA fragmentation (SDF) testing measures the quality of sperm as a DNA package carrier, and it therefore is more significant than the parameters analyzed in previous semen analyses.
Elevated SDF was shown to impair natural fertility and assisted reproductive (ART) outcomes.
SDF can be observed even in men with normal semen analysis results. Damage to sperm DNA can result in longer time to pregnancy, unexplained infertility, recurrent pregnancy loss, Therefore, interventions aimed at explored to potentially improve natural fertility.
This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .
- Conditions
- Unexplained Infertility
- Being tested
- Bilateral Subinguinal microscopic varicocelectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Subinguinal microscopic varicocelectomyProcedure or surgery
Using Leica® Microsystems , Germany. the patient was placed in a supine position after spinal anesthesia administration , The left external inguinal ring was located near the pubic tubercle by palpation, and the incision site was marked below the annulus of the left external ring. A 1.5- to 3-cm oblique incision was made along the skin line. After the tissues were dissected layer by layer, the incision was exposed until the spermatic cord became visible. the spermatic cord was lifted out with Babcock clamp and delivered though the incision and followed by the placement of a nelaton catheter 20 fr below the spermatic cord. The external spermatic vein was located and ligated. The microscopic operation was performed at 10× to 20× magnification.
| Study group | Role | What they receive |
|---|---|---|
| Varicocelectomy group | Experimental | Bilateral Subinguinal microscopic varicocelectomy Receives: Procedure: Bilateral Subinguinal microscopic varicocelectomy |
| Controlled group | No intervention | no intervention , follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
varicocelectomy improved spontaneous pregnancy rates
Sub inguinal microscopic varicocelectomy increase spontaneous pregnancy rates in groups with high sperm DNA fragmentation index in comparison to control group or varicocelectomy group with intermediate or normal sperm DNA fragmentation index
Measured: follow up 1 year post varicocelectomy
Effect of Infertility duration on sperm parameter and pregnancy rate after varicocelectomy
The infertility duration is sub grouped into three according to months of primary infertility and measures changes in sperm concentration , motility ,morphology and changes in spontaneous pregnancy rate in different groups
Measured: follow up 1 year post varicocelectomy
Secondary outcomes (2)
Improvement in Sperm DNA fragmentation index
decrease of sperm DNA fragmentation index after varicocelectomy in group with high sperm DNA fragmentation index > 25 %
Measured: follow up 1 year post varicocelectomy
Changes in sperm concentration , Motility and morphology after varicocelectomy
increasing in sperm concentration , Motility and morphology after varicocelectomy in group with High sperm DNA fragmentation index > 25% in comparison to group with normal sperm DNA fragmentation index
Measured: follow up 1 year post varicocelectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start13 Feb 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd El-Moaty Khalifa, Kafrelsheikh University
- Investigators
- Ahmed A. Khalifa, MSc, Principal investigator, Kafrelsheikh UniversityTarek M. Abdelbaky, MD, Study director, Kafrelsheikh UniversityAyman S. Rashed, MD, Study director, October 6 UniversityKhaled M. Magdy Zeinelabden, MD, Study director, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491251
- Sponsor's protocol ID
- Unexplained male infertility
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dai Y, Liu J, Yuan E, Li Y, Shi Y, Zhang L. Relationship Among Traditional Semen Parameters, Sperm DNA Fragmentation, and Unexplained Recurrent Miscarriage: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2022 Jan 4;12:802632. doi: 10.3389/fendo.2021.802632. eCollection 2021.
PubMed 35058886Guzick DS, Overstreet JW, Factor-Litvak P, Brazil CK, Nakajima ST, Coutifaris C, Carson SA, Cisneros P, Steinkampf MP, Hill JA, Xu D, Vogel DL; National Cooperative Reproductive Medicine Network. Sperm morphology, motility, and concentration in fertile and infertile men. N Engl J Med. 2001 Nov 8;345(19):1388-93. doi: 10.1056/NEJMoa003005.
PubMed 11794171
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
- ClinicalTrials.gov ID
- NCT06491251
- Acronym / sponsor ID
- Unexplained male infertility
- Conditions
- Unexplained Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 9 Jul 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.
This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .
Detailed description
Infertility is defined as the absence of a desired pregnancy following regular, unprotected sexual intercourse for a period of at least 1 year. Over 15% of married couples worldwide experience fertility problems, and 50% of these cases are caused by male factor infertility.
Varicocele is the abnormal enlargement of the veins within the pampiniform plexus. The condition affects approximately 15% of the overall adult male population and 35% of men with primary infertility. Among men with secondary infertility, varicose veins are found in up to 80% of patients.
Only about 20% of all men with varicocele present with infertility. But overall, it is the most frequent abnormality found in infertile men.
Microsurgical varicocelectomy has gradually become the preferred surgical option for varicocele due to its advantages of less surgical damage, lower postoperative recurrence rate, fewer complications, higher postoperative semen quality, and higher postoperative fertility rate.
The two approaches to microsurgical varicocelectomy include the inguinal or subinguinal routes. The subinguinal approach involves the shallow spermatic cord and simple anatomic layers; it does not require the dissection of the external abdominal oblique muscle and allows for the application of spinal anesthesia.
Sub-inguinal approach assisted by microscope magnification is a safe, simple , and effective method for the treatment of sub fertile men and permit significant improvement in DNA fragmentation index and sperm parameters.
Varicocele is linked to male infertility through various nonmanually exclusive mechanisms, including an increase in the production of reactive oxygen species (ROS) that may lead to sperm deoxyribonucleic acid (DNA) damage.
Excessive sperm DNA breaks, so-called sperm DNA fragmentation (SDF), are commonly found in the ejaculates of men with varicocele and fertility-related issues. Although elevated SDF is mainly observed in men with abnormal semen parameters, namely, count, motility, and morphology, it can coexist with normozoospermia.
Semen analysis is the most important test for evaluating male infertility, but it does not provide information regarding all functions of sperm, nor is it sufficient for predicting male fertility potential and the likelihood of success of assisted reproductive technology (ART).
Furthermore, the standards for normal values in semen analysis do not reflect average values, In fact, 15% of patients with male infertility were found to have normal semen analysis results. Therefore, additional tests should be performed due to the limitations of using semen analysis results alone to evaluate male fertility potential.
Sperm DNA fragmentation (SDF) testing measures the quality of sperm as a DNA package carrier, and it therefore is more significant than the parameters analyzed in previous semen analyses.
Elevated SDF was shown to impair natural fertility and assisted reproductive (ART) outcomes.
SDF can be observed even in men with normal semen analysis results. Damage to sperm DNA can result in longer time to pregnancy, unexplained infertility, recurrent pregnancy loss, Therefore, interventions aimed at explored to potentially improve natural fertility.
This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varicocelectomy group | Experimental | Procedure: Bilateral Subinguinal microscopic varicocelectomyBilateral Subinguinal microscopic varicocelectomy |
| Controlled group | No intervention | –no intervention , follow up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients unable to conceive after 12 month of regular and unprotected intercourse
- Male patients aged 18 -45 years old
- Normal semen analysis (concentration, motility and morphology) according to WHO criteria 2021
- Infertile men with clinical varicocele (grade II,III) subjected to varicocelectomy
- No history of other congenital or acquired urogenital diseases
Key exclusion criteria (7 listed)
- History of other congenital or acquired urogenital diseases
- Age outside inclusion criteria
- Grade I varicocele confirmed by ultrasound ( subclinical varicocele )
- Abnormal semen analysis
- Recurrent varicocele
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 |
|---|---|---|
| Bilateral Subinguinal microscopic varicocelectomyUsing Leica® Microsystems , Germany. the patient was placed in a supine position after spinal anesthesia administration , The left external inguinal ring was located near the pubic tubercle by palpation, and the incision site was marked below the annulus of the left external ring. A 1.5- to 3-cm oblique incision was made along the skin line. After the tissues were dissected layer by layer, the incision was exposed until the spermatic cord became visible. the spermatic cord was lifted out with Babcock clamp and delivered though the incision and followed by the placement of a nelaton catheter 20 fr below the spermatic cord. The external spermatic vein was located and ligated. The microscopic operation was performed at 10× to 20× magnification. | Procedure or surgery | Varicocelectomy group |
Primary outcome
varicocelectomy improved spontaneous pregnancy rates
Time frame: follow up 1 year post varicocelectomy
Sub inguinal microscopic varicocelectomy increase spontaneous pregnancy rates in groups with high sperm DNA fragmentation index in comparison to control group or varicocelectomy group with intermediate or normal sperm DNA fragmentation index
Effect of Infertility duration on sperm parameter and pregnancy rate after varicocelectomy
Time frame: follow up 1 year post varicocelectomy
The infertility duration is sub grouped into three according to months of primary infertility and measures changes in sperm concentration , motility ,morphology and changes in spontaneous pregnancy rate in different groups
2 secondary outcomes
Improvement in Sperm DNA fragmentation index
Time frame: follow up 1 year post varicocelectomy
Changes in sperm concentration , Motility and morphology after varicocelectomy
Time frame: follow up 1 year post varicocelectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 35058886Dai Y, Liu J, Yuan E, Li Y, Shi Y, Zhang L. Relationship Among Traditional Semen Parameters, Sperm DNA Fragmentation, and Unexplained Recurrent Miscarriage: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2022 Jan 4;12:802632. doi: 10.3389/fendo.2021.802632. eCollection 2021.
- Background: PubMed 11794171Guzick DS, Overstreet JW, Factor-Litvak P, Brazil CK, Nakajima ST, Coutifaris C, Carson SA, Cisneros P, Steinkampf MP, Hill JA, Xu D, Vogel DL; National Cooperative Reproductive Medicine Network. Sperm morphology, motility, and concentration in fertile and infertile men. N Engl J Med. 2001 Nov 8;345(19):1388-93. doi: 10.1056/NEJMoa003005.
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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.
Ahmed A. Khalifa, MSc principal investigator
Kafrelsheikh University
Tarek M. Abdelbaky, MD study director
Kafrelsheikh University
Ayman S. Rashed, MD study director
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Subinguinal microscopic varicocelectomy in people with Unexplained Infertility, run by Kafrelsheikh 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 7 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 9 Jul 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?
Contact Ahmed A. Khalifa, MSc (00201016183850, Ahmed.med_0571@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
varicocelectomy improved spontaneous pregnancy rates (time frame: follow up 1 year post varicocelectomy). 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?
On the ClinicalTrials.gov record for NCT06491251, which also lists 2 linked publications.
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 9 Jul 2024.