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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Persistent or Recurrent Varicocele on the Operated Side [Срок оценки: 12 months after surgery]

Вторичные конечные точки (12)

• Change in Total Motile Sperm Count [Срок оценки: Baseline and 6 months after surgery]
• Change in Sperm Concentration [Срок оценки: Baseline, 3 months, 6 months, and 12 months after surgery]
• Change in Total Sperm Count [Срок оценки: Baseline, 3 months, 6 months, and 12 months after surgery]
• Change in Progressive Sperm Motility [Срок оценки: Baseline, 3 months, 6 months, and 12 months after surgery]
• Change in Total Sperm Motility [Срок оценки: Baseline, 3 months, 6 months, and 12 months after surgery]
• Change in Normal Sperm Morphology [Срок оценки: Baseline, 3 months, 6 months, and 12 months after surgery]
• Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain [Срок оценки: Baseline, 3 months, 6 months, and 12 months after surgery]
• Number of Couples Achieving Spontaneous Pregnancy [Срок оценки: Up to 12 months after surgery]
• Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy [Срок оценки: Up to 12 months after surgery]
• Operative time [Срок оценки: Intraoperatively]
• Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele [Срок оценки: 12 months after surgery]
• Number of Participants with Postoperative Complications [Срок оценки: Up to 12 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Benha University Hospital — Banhā

Идентификаторы

NCT: NCT07605351 · RC 12-4-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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