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

N/ANot Yet RecruitingNCT07605351

Benha University160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Varicocele

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Persistent or Recurrent Varicocele on the Operated Side

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.

Time frame: 12 months after surgery

Secondary Outcomes

Change in Total Motile Sperm Count

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.

Time frame: Baseline and 6 months after surgery

Change in Sperm Concentration

Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.