Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
2026年5月18日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
160
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ahmed E Zahran, MD
- 電話番号：+2 +20 10 07950278
- メール：Ahmed.ebrahim@fmed.bu.edu.eg
研究場所
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Qalyubia Governorate
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Banhā、Qalyubia Governorate、エジプト、13511
- Benha University Hospital
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コンタクト：
- Ahmed E Zahran, MD
- 電話番号：+2 0 10 07950278
- メール：Ahmed.ebrahim@fmed.bu.edu.eg
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Persistent or Recurrent Varicocele on the Operated Side
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Total Motile Sperm Count
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2028年6月15日
研究の完了 (推定)
2028年6月15日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月18日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RC 12-4-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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