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Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

Sponsor
The Second Hospital of Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02695199
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
23
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic varicocelectomy
  • Procedure: Microscopic Subinguinal varicocelectomy
 N/A

Detailed Description

To compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. To examine the microanatomy of the spermatic cord within suprainguinal portion.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison Between Laparoscopic Doppler Ultrasound Assisted Laparoscopic Varicocelectomy and Microscopic Subinguinal Varicocelectomy
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: laparoscopic varicocelectomy

laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group

Procedure: Laparoscopic varicocelectomy
Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound
Other Names:
  • Laparoscopic varicocelectomy assisted by Doppler ultrasound

    		•
    Sham Comparator: microscopic varicocelectomy

    conventional Microscopic Subinguinal varicocelectomy group

    Procedure: Microscopic Subinguinal varicocelectomy
    Infertile patients with clinically palpable varicoceles were selected to receive microscopic Subinguinal varicocelectomy
    Other Names:
  • Traditional microscopic Subinguinal varicocelectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate [The pregnancy rate was calculated at 1 year of follow-up]

    Secondary Outcome Measures

    1. semen quality assessment [semen quality assessment were checked at 3, 6 and 12 months after surgery.]

      Routine sperm quality check including Count，Morphology and Motility using both the conventional manual method and computer assisted sperm analysis (CASA) systems.

    2. postoperative complications [postoperative complications at 3, 6 and 12 months after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 39 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;

    2. impaired semen quality including sperm concentration <15 million/ml or total motility <40% or progressively motile < 32% (a+b), the 5th edited World Health Organization criteria was referred;

    3. with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;

    4. patient's spouse was healthy in reproduction.

    Exclusion Criteria:

    1. with subclinical varicocele, recurrent varicoceles;

    2. normal semen analyses;

    3. other reasons of infertility than varicoceles;

    4. refusing to enter randomization;

    5. female partner older than 35 years;

    6. with abnormal level of serum hormones;

    7. female factor infertility;

    8. with significant surgical diseases, congenital diseases or endocrine diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Hospital of Shandong University Jinan Shandong China 250033

    Sponsors and Collaborators

    • The Second Hospital of Shandong University

    Investigators

    • Study Director: Mingzhen Yuan, MD, Second hospital of Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Second Hospital of Shandong University
    ClinicalTrials.gov Identifier:
    NCT02695199
    Other Study ID Numbers:
    • 49557309-6
    First Posted:
    Mar 1, 2016
    Last Update Posted:
    Mar 1, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by The Second Hospital of Shandong University
    Doppler Ultrasound
    Laparoscopic
    Microscopic Subinguinal Varicocelectomy
    Additional relevant MeSH terms:
    Varicocele

    Study Results

    No Results Posted as of Mar 1, 2016