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Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility

18 maggio 2026 aggiornato da: Ahmed Ebrahim Zahran, Benha University

Selective Extended Microsurgical Venous Stripping Versus Standard Microsurgical Subinguinal Varicocelectomy in Infertile Men With Abnormal Semen Parameters: A Prospective Randomized Controlled Trial

Varicocele is a common correctable cause of male infertility and may be associated with abnormal semen parameters, impaired testicular function, and scrotal discomfort. Microsurgical subinguinal varicocelectomy is a commonly used surgical approach because it allows careful preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels under magnification. However, persistent or recurrent varicocele may still occur after surgery, possibly because of missed or persistent venous channels.

This randomized controlled trial will compare two surgical techniques in infertile men with clinically palpable varicocele and abnormal semen parameters. Participants will be randomly assigned to either microsurgical subinguinal varicocelectomy with selective extended venous stripping or standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division.

The main purpose of the study is to determine whether selective extended venous stripping reduces the rate of clinically and Doppler-confirmed persistent or recurrent varicocele at 12 months after surgery compared with the standard microsurgical technique. The study will also compare semen parameter improvement, pain improvement in participants with baseline pain, pregnancy outcomes, operative time, postoperative complications, and the need for additional treatment during 12 months of follow-up.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

160

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egitto, 13511

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Male patients aged 18 to 50 years.
  • Couple infertility for at least 12 months.
  • Clinically palpable grade I to III varicocele confirmed by physical examination.
  • Abnormal semen parameters documented on at least two semen analyses performed 2 to 4 weeks apart according to World Health Organization laboratory standards.
  • Female partner evaluation completed or planned, with no untreated severe female factor that would make natural conception impossible.
  • Willingness to comply with postoperative follow-up at 3, 6, and 12 months.
  • Written informed consent.

Exclusion Criteria:

  • Azoospermia or cryptozoospermia, defined as absence of sperm in the native ejaculate on at least two baseline semen analyses, including cases in which sperm are detected only after centrifugation.
  • Known clinically significant chromosomal or genetic abnormality that independently explains severe male infertility, when identified before enrollment.
  • Previous varicocelectomy of the index side.
  • Previous inguinal, scrotal, or retroperitoneal surgery that may alter spermatic cord anatomy.
  • Subclinical varicocele only.
  • Isolated scrotal pain with normal semen parameters.
  • Hypogonadotropic hypogonadism requiring hormonal induction therapy.
  • Testosterone therapy within the previous 6 months.
  • Use of anti-estrogens, gonadotropins, or aromatase inhibitors within the previous 3 months.
  • Active genitourinary infection.
  • Testicular tumor or history of testicular cancer.
  • Severe systemic disease contraindicating surgery or anesthesia.
  • Inability to provide informed consent.
  • Inability or unwillingness to complete follow-up.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Microsurgical Varicocelectomy With Selective Extended Venous
Participants randomized to this arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping. Suitable clinically relevant dilated veins will be circumferentially dissected, mobilized, stripped over a defined segment, ligated, and divided when predefined safety criteria are met. Veins unsuitable for safe stripping will be treated by standard ligation and division, with documentation of the reason for non-stripping.
Procedura: Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping
Microsurgical subinguinal varicocelectomy performed under magnification with preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Favorable clinically relevant dilated veins will be dissected, mobilized, stripped over a defined segment, ligated, and divided. Veins not suitable for safe stripping will be treated by standard ligation and division.
Comparatore attivo: Standard Microsurgical Subinguinal Varicocelectomy
Participants randomized to this arm will undergo standard microsurgical subinguinal varicocelectomy with conventional ligation and division of identified veins requiring treatment under microscopic magnification. No venous stripping will be performed.
Procedura: Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation
Standard microsurgical subinguinal varicocelectomy performed under magnification. Identified veins requiring treatment will be isolated, ligated, and divided while preserving the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Venous stripping will not be performed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Persistent or Recurrent Varicocele on the Operated Side
Lasso di tempo: 12 months after surgery
Persistent or recurrent varicocele will be defined as a palpable varicocele on standing physical examination confirmed by color Doppler ultrasound showing pampiniform plexus vein diameter of at least 3.0 millimeters with reflux lasting more than 2 seconds during Valsalva maneuver. For bilateral surgery, recurrence on either operated side will be counted as recurrence.
12 months after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Total Motile Sperm Count
Lasso di tempo: Baseline and 6 months after surgery
Total motile sperm count will be calculated as semen volume multiplied by sperm concentration multiplied by total motility percentage. The mean of two baseline semen analyses will be used for baseline assessment.
Baseline and 6 months after surgery
Change in Sperm Concentration
Lasso di tempo: Baseline, 3 months, 6 months, and 12 months after surgery
Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.
Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Count
Lasso di tempo: Baseline, 3 months, 6 months, and 12 months after surgery
Total sperm count will be measured by semen analysis according to World Health Organization laboratory standards.
Baseline, 3 months, 6 months, and 12 months after surgery
Change in Progressive Sperm Motility
Lasso di tempo: Baseline, 3 months, 6 months, and 12 months after surgery
Progressive sperm motility will be measured as the percentage of sperm showing progressive movement on semen analysis.
Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Motility
Lasso di tempo: Baseline, 3 months, 6 months, and 12 months after surgery
Total sperm motility will be measured as the percentage of motile sperm on semen analysis.
Baseline, 3 months, 6 months, and 12 months after surgery
Change in Normal Sperm Morphology
Lasso di tempo: Baseline, 3 months, 6 months, and 12 months after surgery
Normal sperm morphology will be measured as the percentage of sperm with normal morphology on semen analysis.
Baseline, 3 months, 6 months, and 12 months after surgery
Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain
Lasso di tempo: Baseline, 3 months, 6 months, and 12 months after surgery
Scrotal pain will be assessed using a 0 to 10 visual analog scale among participants who report baseline varicocele-related scrotal pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain.
Baseline, 3 months, 6 months, and 12 months after surgery
Number of Couples Achieving Spontaneous Pregnancy
Lasso di tempo: Up to 12 months after surgery
Spontaneous pregnancy in the female partner will be recorded during follow-up and reported separately from assisted reproductive technology-related pregnancy.
Up to 12 months after surgery
Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy
Lasso di tempo: Up to 12 months after surgery
Pregnancy achieved using assisted reproductive technology will be recorded during follow-up and reported separately from spontaneous pregnancy.
Up to 12 months after surgery
Operative time
Lasso di tempo: Intraoperatively
Operative time will be measured from skin incision to completion of wound closure.
Intraoperatively
Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele
Lasso di tempo: 12 months after surgery
Any additional surgical, radiologic, or other intervention for persistent or recurrent varicocele will be recorded.
12 months after surgery
Number of Participants with Postoperative Complications
Lasso di tempo: Up to 12 months after surgery
Postoperative complications will be recored after surgery. Complications will be graded according to the Clavien-Dindo classification of postoperative surgical complications, which classifies complications based on the treatment required, ranging from Grade I for minor deviations from normal recovery to Grade V for death.
Up to 12 months after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Benha University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

15 giugno 2028

Completamento dello studio (Stimato)

15 giugno 2028

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RC 12-4-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, operative variables, semen analysis parameters, pain scores, Doppler ultrasound findings, pregnancy outcomes, recurrence outcomes, and postoperative complications. No directly identifying participant information will be shared.

Periodo di condivisione IPD

Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.

Criteri di accesso alla condivisione IPD

Data will be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator and study investigators. Data will be provided only after approval of the request and, when required, completion of a data sharing agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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