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Status unknownNCT02695199Updated Mar 1, 2016

Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

An interventional study of Laparoscopic varicocelectomy and Microscopic Subinguinal varicocelectomy in Varicocele, sponsored by The Second Hospital of Shandong University. Status unknown at 1 site in China. Open to male participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2016-03-01.

Sponsored by The Second Hospital of Shandong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Varicocele

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Keywords

  • Doppler Ultrasound
  • Laparoscopic
  • Microscopic Subinguinal Varicocelectomy
03

In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 36 interventional studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

The Second Hospital of Shandong University is the lead sponsor of 35 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    laparoscopic varicocelectomy

    laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group

    Procedure: Laparoscopic varicocelectomy

  • Sham comparator
    microscopic varicocelectomy

    conventional Microscopic Subinguinal varicocelectomy group

    Procedure: Microscopic Subinguinal varicocelectomy

Interventions

  • ProcedureLaparoscopic varicocelectomy

    Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound

    Also known as: Laparoscopic varicocelectomy assisted by Doppler ultrasound

  • ProcedureMicroscopic Subinguinal varicocelectomy

    Infertile patients with clinically palpable varicoceles were selected to receive microscopic Subinguinal varicocelectomy

    Also known as: Traditional microscopic Subinguinal varicocelectomy

06

What researchers measure

Primary outcomes

  1. Pregnancy rate

    Time frame: The pregnancy rate was calculated at 1 year of follow-up

Secondary outcomes

  1. semen quality assessment

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

    Time frame: semen quality assessment were checked at 3, 6 and 12 months after surgery.

  2. postoperative complications

    Time frame: postoperative complications at 3, 6 and 12 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Second Hospital of Shandong University
    Jinan, Shandong 250033, China
    Recruiting
    • Mingzhen Yuan, PHD · Contactyuanmingzhen2005@126.com · +8615053155899
    • Liqiang Guo, MD · Contactglq_66@yeah.net · +8618253132651
    • Liqiang Guo, MD · Principal investigator
    • Wendong Sun, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02695199
Lead sponsor
The Second Hospital of Shandong University
Responsible party
Sponsor
First posted
Mar 1, 2016
Start date
Jan 2016
Primary completion
Jan 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Mar 1, 2016

Study contacts

Shengtian Zhao, PHD
Contact
398139849@qq.com
+86053185875401
Mingzhen Yuan, MD
study director · Second hospital of Shandong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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