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Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia

S

South Valley University

Status

Enrolling

Conditions

Non-obstructive Azoospermia

Treatments

Procedure: varicocelectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07008495
Non-Obstructive Azoospermia

Details and patient eligibility

About

A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility.

Male factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.

Full description

Generally, azoospermia is classified as obstructive azoospermia (OA) or non-obstructive azoospermia (NOA). While OA is obviously caused by obstruction, NOA has many possible causes and is more difficult to manage.

Non-obstructive azoospermia (NOA) is most often a result of primary testicular dysfunction, Varicoceles are found in 20% of the general male population, in up to 40% of men with infertility, and specifically 4.3-13.3% of men with NOA.

The role of varicoceles in NOA has not been fully elucidated. The current best practice statement on the evaluation of azoospermic males from the AUA acknowledges that impaired spermatogenesis associated with varicoceles may be reversible but does not give a clear recommendation for management.

The primary advantage of varicocelectomy in cases of NOA is the possibility of getting motile sperms in the ejaculate. Other benefit of varicocele repairs in azoospermic men is that there are increased success rates of assisted reproductive techniques (ART) such as intracytoplasmic sperm injection (ICSI) or testicular sperm extraction (TESE).

Enrollment

50 estimated patients

Sex

Male

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men with non obstructive azoospermia.
  • Clinically palpable varicocele ( unilateral or bilateral ).

Exclusion criteria

  • Known cases of obstructive azoospermia.
  • Non palpable varicocele.
  • Uncorrectable female causes of infertility.
  • genetic abnormalities like klinefelter syndrome.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Group of varicocele ligation
Active Comparator group
Description:
About 25 male patients will undergo varicocele ligation then microTESE.
Treatment:
Procedure: varicocelectomy
Group of TESE
Active Comparator group
Description:
About 25 male patients will undergo microTESE without varicocele ligation.
Treatment:
Procedure: varicocelectomy

Trial contacts and locations

1

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Central trial contact

Yacoub Nagah Abdelwahab, Resident

Data sourced from clinicaltrials.gov

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