Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility

NCT06491251 | Recruiting

• 1 other identifier: Unexplained male infertility
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 .

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (2)

• 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

  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

  follow up 1 year post varicocelectomy

Secondary Outcomes (2)

• Improvement in Sperm DNA fragmentation index

  follow up 1 year post varicocelectomy

• Changes in sperm concentration , Motility and morphology after varicocelectomy

  follow up 1 year post varicocelectomy

Study Arms (2)

Varicocelectomy group

EXPERIMENTAL

Bilateral Subinguinal microscopic varicocelectomy

Procedure: Bilateral Subinguinal microscopic varicocelectomy

Controlled group

NO INTERVENTION

no intervention , follow up

Interventions

Bilateral Subinguinal microscopic varicocelectomy PROCEDURE

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.

Varicocelectomy group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• History of other congenital or acquired urogenital diseases
• 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)

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, 33516, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 35058886 BACKGROUND

• 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.

  PMID: 11794171 BACKGROUND

Study Officials

• Ahmed A. Khalifa, MSc

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

• Tarek M. Abdelbaky, MD

  Kafrelsheikh University

  STUDY DIRECTOR

• Ayman S. Rashed, MD

  October 6 University

  STUDY DIRECTOR

• Khaled M. Magdy Zeinelabden, MD

  Kafrelsheikh University

  STUDY DIRECTOR

Central Study Contacts

Ahmed A. Khalifa, MSc

CONTACT

00201016183850; Ahmed.med_0571@med.kfs.edu.eg

Ayman S. Rashed, MD

CONTACT

00201006023284; aymanrashed@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 9, 2024
• Study Start: February 13, 2023
• Primary Completion: July 15, 2024
• Study Completion: August 1, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-06

Locations

EG (1)