Clinical trial NCT06491251: Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
Official title: Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unexplained Infertility
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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 .

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: varicocelectomy improved spontaneous pregnancy rates
timeFrame: follow up 1 year post varicocelectomy
measure: Effect of Infertility duration on sperm parameter and pregnancy rate after varicocelectomy
timeFrame: follow up 1 year post varicocelectomy
Secondary outcomes:
measure: Improvement in Sperm DNA fragmentation index
timeFrame: follow up 1 year post varicocelectomy
measure: Changes in sperm concentration , Motility and morphology after varicocelectomy
timeFrame: follow up 1 year post varicocelectomy
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Ahmed A. Khalifa, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kafrelsheikh University
name: Tarek M. Abdelbaky, MD
role: STUDY_DIRECTOR
affiliation: October 6 University
name: Ayman S. Rashed, MD
role: STUDY_DIRECTOR
affiliation: Kafrelsheikh University
name: Khaled M. Magdy Zeinelabden, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.