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

18 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

160

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Egipt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egipt, 13511

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Aktywny 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Persistent or Recurrent Varicocele on the Operated Side
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Total Motile Sperm Count
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Benha University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 czerwca 2028

Ukończenie studiów (Szacowany)

15 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

18 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RC 12-4-2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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