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

18 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

160

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Egito
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egito, 13511

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Procedimento: 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.
Comparador Ativo: 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.
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Persistent or Recurrent Varicocele on the Operated Side
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Total Motile Sperm Count
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Benha University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

15 de junho de 2028

Conclusão do estudo (Estimado)

15 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RC 12-4-2025

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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