NCT05799742

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

January 1, 2019

Enrollment Period

4 years

First QC Date

February 17, 2023

Last Update Submit

April 3, 2023

Conditions

Inguinal Hernia Bilateral

Keywords

Inguinal herniaInfertilityLaparoscopy

Outcome Measures

Primary Outcomes (22)

  • Sperm Volume

    Sperm Volume (in ml) measured by Semen analysis

    Preoperative

  • Sperm concentration

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

    Preoperative

  • Sperm number

    Sperm number in million measured by Semen analysis

    Preoperative

  • Sperm motility

    Sperm motility in % of progression measured by Semen analysis

    Preoperative

  • Sperm morphology

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

    Preoperative

  • Testicular volume

    Testicular volume, in cm3, measured by testicular ultrasound

    Preoperative

  • Testicular vascularization

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

    Preoperative

  • Sperm Volume

    Sperm Volume (in ml) measured by Semen analysis

    90th postoperative day

  • Sperm concentration

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

    90th postoperative day

  • Sperm number

    Sperm number in million measured by Semen analysis

    90th postoperative day

  • Sperm motility

    Sperm motility in % of progression measured by Semen analysis

    90th postoperative day

  • Sperm morphology

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

    90th postoperative day

  • Testicular volume

    Testicular volume, in cm3, measured by testicular ultrasound

    90th postoperative day

  • Testicular vascularization

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

    90th postoperative day

  • Sperm Volume

    Sperm Volume (in ml) measured by Semen analysis

    180th postoperative day

  • Sperm concentration

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

    180th postoperative day

  • Sperm number

    Sperm number in million measured by Semen analysis

    180th postoperative day

  • Sperm motility

    Sperm motility in % of progression measured by Semen analysis

    180th postoperative day

  • Sperm morphology

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

    180th postoperative day

  • Semen analysis

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

    180th postoperative day

  • Testicular volume

    Testicular volume, in cm3, measured by testicular ultrasound

    180th postoperative day

  • Testicular vascularization

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

    180th postoperative day

Secondary Outcomes (22)

  • Follicle Stimulating Hormone (FSH) dosage

    Preoperative

  • Luteinizing Hormone (LH) dosage

    Preoperative

  • Testosterone Hormone dosage

    Preoperative

  • Sex hormone-binding globulin (SHGB) dosage

    Preoperative

  • Sexual activity

    Preoperative

  • +17 more secondary outcomes

Study Arms (2)

Lichtenstein

ACTIVE COMPARATOR

Conventional approach

Procedure: Bilateral hernioplasty

Laparoscopy

EXPERIMENTAL

Experimental approach

Procedure: Bilateral hernioplasty

Interventions

Bilateral hernioplastyPROCEDURE
LaparoscopyLichtenstein

Eligibility Criteria

Age19 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • Damous SHB, Damous LL, Borges VA, Fontella AK, Miranda JDS, Koike MK, Saito OC, Birolini CAV, Utiyama EM. Bilateral inguinal hernia repair and male fertility: a randomized clinical trial comparing Lichtenstein versus laparoscopic transabdominal preperitoneal (TAPP) technique. Surg Endosc. 2023 Dec;37(12):9263-9274. doi: 10.1007/s00464-023-10499-8. Epub 2023 Oct 25.

    PMID: 37880447DERIVED

MeSH Terms

Conditions

Hernia, InguinalInfertility

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking couldn't be possible because of the surgical technique
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial with two groups, in according to hernioplasty correction approach
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

April 5, 2023

Study Start

June 1, 2016

Primary Completion

June 1, 2020

Study Completion

December 15, 2020

Last Updated

April 5, 2023

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

All individual participant data that underlie individual participant data that underlie collected during the trial, after deidentification (text, tables, figures, and appendices) will be shared. Study Protocol also will be available. Data will be available immediately following publication, no end dates, to anyone who wishes to access the data, for any types of analyses. Proposals should be directed to sergio.damous@hc.fm.usp.br

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available immediately following publication, no end dates.
Access Criteria
Proposals should be directed to sergio.damous@hc.fm.usp.br

Locations

BR(1)