Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
18 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
160
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Ahmed E Zahran, MD
- Номер телефона: +2 +20 10 07950278
- Электронная почта: Ahmed.ebrahim@fmed.bu.edu.eg
Места учебы
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Египет, 13511
- Benha University Hospital
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Контакт:
- Ahmed E Zahran, MD
- Номер телефона: +2 0 10 07950278
- Электронная почта: Ahmed.ebrahim@fmed.bu.edu.eg
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
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Активный компаратор: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Persistent or Recurrent Varicocele on the Operated Side
Временное ограничение: 12 months after surgery
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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.
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12 months after surgery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Total Motile Sperm Count
Временное ограничение: Baseline and 6 months after surgery
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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.
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Baseline and 6 months after surgery
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Change in Sperm Concentration
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after surgery
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Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.
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Baseline, 3 months, 6 months, and 12 months after surgery
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Change in Total Sperm Count
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after surgery
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Total sperm count will be measured by semen analysis according to World Health Organization laboratory standards.
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Baseline, 3 months, 6 months, and 12 months after surgery
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Change in Progressive Sperm Motility
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after surgery
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Progressive sperm motility will be measured as the percentage of sperm showing progressive movement on semen analysis.
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Baseline, 3 months, 6 months, and 12 months after surgery
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Change in Total Sperm Motility
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after surgery
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Total sperm motility will be measured as the percentage of motile sperm on semen analysis.
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Baseline, 3 months, 6 months, and 12 months after surgery
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Change in Normal Sperm Morphology
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after surgery
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Normal sperm morphology will be measured as the percentage of sperm with normal morphology on semen analysis.
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Baseline, 3 months, 6 months, and 12 months after surgery
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Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after surgery
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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.
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Baseline, 3 months, 6 months, and 12 months after surgery
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Number of Couples Achieving Spontaneous Pregnancy
Временное ограничение: Up to 12 months after surgery
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Spontaneous pregnancy in the female partner will be recorded during follow-up and reported separately from assisted reproductive technology-related pregnancy.
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Up to 12 months after surgery
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Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy
Временное ограничение: Up to 12 months after surgery
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Pregnancy achieved using assisted reproductive technology will be recorded during follow-up and reported separately from spontaneous pregnancy.
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Up to 12 months after surgery
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Operative time
Временное ограничение: Intraoperatively
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Operative time will be measured from skin incision to completion of wound closure.
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Intraoperatively
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Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele
Временное ограничение: 12 months after surgery
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Any additional surgical, radiologic, or other intervention for persistent or recurrent varicocele will be recorded.
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12 months after surgery
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Number of Participants with Postoperative Complications
Временное ограничение: Up to 12 months after surgery
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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.
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Up to 12 months after surgery
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 июня 2026 г.
Первичное завершение (Оцененный)
15 июня 2028 г.
Завершение исследования (Оцененный)
15 июня 2028 г.
Даты регистрации исследования
Первый отправленный
18 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
18 мая 2026 г.
Первый опубликованный (Действительный)
22 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RC 12-4-2025
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена IPD
Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
Критерии совместного доступа к 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .