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

18. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

160

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13511

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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.
Aktiv komparator: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Persistent or Recurrent Varicocele on the Operated Side
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Total Motile Sperm Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Benha University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

15. juni 2028

Studiet fullført (Antatt)

15. juni 2028

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RC 12-4-2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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