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Clinical trial Recruiting at 1 site Interventional Ages 18 to 45 Men only

Single infrapubic versus bilateral subinguinal microsurgical varicocelectomy for bilateral varicocele

Official title: Single Infrapubic Versus Bilateral Subinguinal Approaches for Bilateral Microsurgical Varicocelectomy: A Prospective Randomized Controlled Trial

Run by Beni-Suef University · NCT07650955 · Data updated 2026-11-12

This trial tests whether a single infrapubic approach can fix both varicoceles more quickly and with less pain than the standard two-incision bilateral approach in men with infertility.

Quick facts

Study typeInterventional
Ages18 Years to 45 Years
SexMen only
Enrollment40 (estimated)
SponsorBeni-Suef University
Academic / other
Locations1 site (Banī Suwayf, Beni Suweif Governorate)
StatusRecruiting
StartedJune 8, 2026
Main results expectedApril 2027
Study endsMay 2027
Registry record updatedJune 16, 2026
Trial IDNCT07650955 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18–45 with clinically palpable bilateral grade II/III varicoceles, infertility or abnormal semen analysis, and confirmed ultrasound findings who are suitable for microsurgical repair and consent to randomization.

Probably not a fit

Men with unilateral varicocele, subclinical varicoceles, prior scrotal surgery distorting anatomy, or non-inferable infertility factors may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized trial compares a single midline infrapubic microsurgical varicocelectomy to the conventional bilateral subinguinal microsurgical approach in adult men with clinically palpable bilateral varicoceles. Outcomes include postoperative pain, analgesic use, time to resume normal activities, operative time, scar satisfaction, wound complications, recurrence, and other safety measures during follow-up. Eligible participants are men aged 18 to 45 with grade II/III bilateral varicoceles, infertility or abnormal semen analysis, and confirmed ultrasound findings, whose partners have been evaluated for female-factor infertility. The study aims to determine if the infrapubic approach reduces morbidity while achieving similar or better effectiveness compared with the traditional method.

Why it matters

Potential benefit: If successful, patients could experience less postoperative pain and quicker return to daily activities with a single incision while achieving comparable surgical outcomes.

How similar studies have gone: Previous microsurgical varicocelectomy studies show benefits of meticulous microsurgery; this specific infrapubic single-incision approach is being evaluated for potential reduced morbidity.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male patients aged 18 to 45 years.
* Clinically palpable bilateral varicocele, grade II or grade III.
* Diagnosis confirmed by color Doppler ultrasound.
* Infertility for at least 12 months and/or abnormal semen analysis.
* Female partner evaluation performed or planned to exclude major uncorrected female-factor infertility.
* Patient fit for surgery and anesthesia.
* Written informed consent provided by the participant.

Exclusion Criteria:

* Subclinical varicocele detected only by Doppler ultrasound.
* Unilateral varicocele.
* Recurrent varicocele after previous surgery, embolization, or sclerotherapy.
* Previous inguinal, scrotal, pelvic, or penile surgery likely to distort surgical anatomy.
* Associated inguinal hernia, hydrocele, spermatocele, epididymal cyst, or other scrotal condition requiring simultaneous surgery.
* Azoospermia, especially suspected non-obstructive azoospermia.
* Active urinary tract or genital infection.
* Coagulopathy or anticoagulant therapy that cannot be safely interrupted.
* Severe obesity, defined as body mass index greater than 40 kg/m², or any anatomical condition preventing safe exposure by either surgical approach.
* Refusal to participate or inability to complete follow-up.

Where it's running

  • Department of Urology- Beni-Suef University Hospitals
    Banī Suwayf, Beni Suweif Governorate, Egypt     Recruiting

Study contacts

  • Principal investigator: Hany F Badawy, MD — Faculty of medicine Beni-Suef University
  • Study coordinator: Hany F Badawy, MD
  • Email: HANYFATHY86@GMAIL.COM
  • Phone: +201149525028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.