Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
2026년 5월 18일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
160
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ahmed E Zahran, MD
- 전화번호: +2 +20 10 07950278
- 이메일: Ahmed.ebrahim@fmed.bu.edu.eg
연구 장소
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, 이집트, 13511
- Benha University Hospital
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연락하다:
- Ahmed E Zahran, MD
- 전화번호: +2 0 10 07950278
- 이메일: Ahmed.ebrahim@fmed.bu.edu.eg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Persistent or Recurrent Varicocele on the Operated Side
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Total Motile Sperm Count
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2028년 6월 15일
연구 완료 (추정된)
2028년 6월 15일
연구 등록 날짜
최초 제출
2026년 5월 18일
QC 기준을 충족하는 최초 제출
2026년 5월 18일
처음 게시됨 (실제)
2026년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC 12-4-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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