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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ahmed A. Khalifa, MSc contact

00201016183850

Ahmed.med_0571@med.kfs.edu.eg

Ayman S. Rashed, MD contact

00201006023284

aymanrashed@msn.com

Egypt1 site, 1 recruiting
  • Kafrelsheikh University

    Kafr ash Shaykh, 33516

    Ahmed A. Khalifa, MCs, 00201016183850, Ahmed.med_0571@med.kfs.edu.eg

    Recruiting

Other trials in Egypt

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 .

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 groups in NCT06491251
Study groupRoleWhat they receive
Varicocelectomy groupExperimentalBilateral Subinguinal microscopic varicocelectomy
Receives: Procedure: Bilateral Subinguinal microscopic varicocelectomy
Controlled groupNo interventionno intervention , follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. 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

  2. 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.

  1. First posted9 Jul 2024
  2. Study start13 Feb 2023
  3. Primary completion15 Jul 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

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)
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 35058886
  • Guzick 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

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.

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