Health TrialsbyHealthPanel

Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility

ConditionUnexplained Infertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorKafrelsheikh University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of other congenital or acquired urogenital diseases

Age outside inclusion criteria

Grade I varicocele confirmed by ultrasound ( subclinical varicocele )

Abnormal semen analysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bilateral Subinguinal microscopic varicocelectomy

    Procedure/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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Varicocelectomy groupExperimental treatment 1 intervention
Group B: Controlled groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
follow up 1 year post varicocelectomy

Secondary outcomes

1

Improvement in Sperm DNA fragmentation index

decrease of sperm DNA fragmentation index after varicocelectomy in group with high sperm DNA fragmentation index \> 25 %

Time frame
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

Time frame
follow up 1 year post varicocelectomy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov
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