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Completed

NCT Number: NCT05799742

Inguinal Hernia Repair and Male Fertility

General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches

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Key information

Conditions

Inguinal Hernia Bilateral Genital Diseases Hernia Hernia, Abdominal Hernia, Inguinal Infertility Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

About this study

Specific objectives: To correlate pre and postoperative data (90 and 180 days) of adult men, according to biochemistry parameters (hemogram and CRP), autoimmune (anti-sperm antibodies), hormonal (FSH, LH and testosterone), perfusion and volume testicular (USG of testicles with Doppler), spermogram, sexual changes, pain and quality of life (standard questionnaires).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age between 19 and 60 years old
  • Bilateral inguinal hernia
  • Primary and reducible inguinal hernia

Exclusion criteria

  • Age less than 19 or more than 60 years old
  • ASA >III
  • Genito-urinary infection
  • Immunodeficiency
  • History of testicular trauma2
  • History of surgery or pelvic radiotherapy
  • History of testicular disease
  • Fertility problems or sexual
  • Illness that can be infertile
  • Recurrent hernia
  • Unilateral hernia
  • Femoral or inguine-scrotal hernia
  • Imprisoned hernia
  • Use of Gonadotrophins
  • Use of anabolic steroids

Treatment and study plan

Bilateral hernioplasty

Procedure

Primary outcomes

  1. Sperm Volume

    Time frame: Preoperative

    Sperm Volume (in ml) measured by Semen analysis

  2. Sperm concentration

    Time frame: Preoperative

    Sperm concentration (million sperm/ml) measured by Semen analysis

  3. Sperm number

    Time frame: Preoperative

    Sperm number in million measured by Semen analysis

  4. Sperm motility

    Time frame: Preoperative

    Sperm motility in % of progression measured by Semen analysis

  5. Sperm morphology

    Time frame: Preoperative

    Sperm morphology, according to the Kruger classification, evaluated by Semen analysis

  6. Testicular volume

    Time frame: Preoperative

    Testicular volume, in cm3, measured by testicular ultrasound

  7. Testicular vascularization

    Time frame: Preoperative

    Testicular vascularization, normal or not, measured by testicular Doppler ultrasound

  8. Sperm Volume

    Time frame: 90th postoperative day

    Sperm Volume (in ml) measured by Semen analysis

  9. Sperm concentration

    Time frame: 90th postoperative day

    Sperm concentration (million sperm/ml) measured by Semen analysis

  10. Sperm number

    Time frame: 90th postoperative day

    Sperm number in million measured by Semen analysis

  11. Sperm motility

    Time frame: 90th postoperative day

    Sperm motility in % of progression measured by Semen analysis

  12. Sperm morphology

    Time frame: 90th postoperative day

    Sperm morphology, according to the Kruger classification, evaluated by Semen analysis

  13. Testicular volume

    Time frame: 90th postoperative day

    Testicular volume, in cm3, measured by testicular ultrasound

  14. Testicular vascularization

    Time frame: 90th postoperative day

    Testicular vascularization, normal or not, measured by testicular Doppler ultrasound

  15. Sperm Volume

    Time frame: 180th postoperative day

    Sperm Volume (in ml) measured by Semen analysis

  16. Sperm concentration

    Time frame: 180th postoperative day

    Sperm concentration (million sperm/ml) measured by Semen analysis

  17. Sperm number

    Time frame: 180th postoperative day

    Sperm number in million measured by Semen analysis

  18. Sperm motility

    Time frame: 180th postoperative day

    Sperm motility in % of progression measured by Semen analysis

  19. Sperm morphology

    Time frame: 180th postoperative day

    Sperm morphology, according to the Kruger classification, evaluated by Semen analysis

  20. Semen analysis

    Time frame: 180th postoperative day

    Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)

  21. Testicular volume

    Time frame: 180th postoperative day

    Testicular volume, in cm3, measured by testicular ultrasound

  22. Testicular vascularization

    Time frame: 180th postoperative day

    Testicular vascularization, normal or not, measured by testicular Doppler ultrasound

Secondary outcomes

  1. Follicle Stimulating Hormone (FSH) dosage

    Time frame: Preoperative

    Serum FSH (IU/L)

  2. Luteinizing Hormone (LH) dosage

    Time frame: Preoperative

    Serum LH (IU/L)

  3. Testosterone Hormone dosage

    Time frame: Preoperative

    Serum Testosterone (ng/dl)

  4. Sex hormone-binding globulin (SHGB) dosage

    Time frame: Preoperative

    Serum SHGB (nmol/L)

  5. Sexual activity

    Time frame: Preoperative

    Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)

  6. Quality-of-life evaluation (SF-36 questionnaire)

    Time frame: Preoperative

    SF36 Domains: Role physical, Physical function, Role emotional, Energy, Emotional health, Social functioning, Bodily pain and General health. Scale ranging from 0 to 100, where zero is the worst state and 100 is the best.

  7. Postoperative pain

    Time frame: 7th postoperative day

    Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain

  8. Postoperative pain

    Time frame: 30th postoperative day

    Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain

  9. Follicle Stimulating Hormone (FSH) dosage

    Time frame: 90th postoperative day

    Serum FSH (IU/L)

  10. Luteinizing Hormone (LH) dosage

    Time frame: 90th postoperative day

    Serum LH (IU/L)

  11. Testosterone Hormone dosage

    Time frame: 90th postoperative day

    Testosterone (ng/dl)

  12. Sex hormone-binding globulin (SHGB) dosage

    Time frame: 90th postoperative day

    Serum SHGB (nmol/L)

  13. Sexual activity

    Time frame: 90th postoperative day

    Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)

  14. Quality-of-life evaluation (SF-36 questionnaire)

    Time frame: 90th postoperative day

    SF36 Domains: Role physical, Physical function, Role emotional, Energy, Emotional health, Social functioning, Bodily pain and General health. Scale ranging from 0 to 100, where zero is the worst state and 100 is the best.

  15. Postoperative pain

    Time frame: 90th postoperative day

    Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain

  16. Follicle Stimulating Hormone (FSH) dosage

    Time frame: 180th postoperative day

    Serum FSH (IU/L)

  17. Luteinizing Hormone (LH) dosage

    Time frame: 180th postoperative day

    Serum LH (IU/L)

  18. Testosterone Hormone dosage

    Time frame: 180th postoperative day

    Serum Testosterone (ng/dl)

  19. Sex hormone-binding globulin (SHGB) dosage

    Time frame: 180th postoperative day

    Serum SHGB (nmol/L)

  20. Sexual activity

    Time frame: 180th postoperative day

    Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)

  21. Quality-of-life evaluation (SF-36 questionnaire)

    Time frame: 180th postoperative day

    SF36 Domains: Role physical, Physical function, Role emotional, Energy, Emotional health, Social functioning, Bodily pain and General health. Scale ranging from 0 to 100, where zero is the worst state and 100 is the best.

  22. Postoperative pain

    Time frame: 180th postoperative day

    Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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