Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491251
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-24
Brief Title:
Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None