Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

Comparison Between Laparoscopic Doppler Ultrasound Assisted Laparoscopic Varicocelectomy and Microscopic Subinguinal Varicocelectomy

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.

Study Overview

• Status: Unknown
• Conditions: Varicocele
• Intervention / Treatment: Procedure: Laparoscopic varicocelectomy; Procedure: Microscopic Subinguinal varicocelectomy

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengtian Zhao, PHD; Phone Number: +86053185875401; Email: 398139849@qq.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • Recruiting
      • Second Hospital of Shandong University
      • Contact: Mingzhen Yuan, PHD; Phone Number: +8615053155899; Email: yuanmingzhen2005@126.com
      • Contact: Liqiang Guo, MD; Phone Number: +8618253132651; Email: glq_66@yeah.net
      • Principal Investigator: Liqiang Guo, MD
      • Sub-Investigator: Wendong Sun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pregnancy rate	The pregnancy rate was calculated at 1 year of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	semen quality assessment were checked at 3, 6 and 12 months after surgery.
postoperative complications		postoperative complications at 3, 6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University
• Investigators: Study Director: Mingzhen Yuan, MD, Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (ESTIMATE): March 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 1, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Doppler Ultrasound; Laparoscopic; Microscopic Subinguinal Varicocelectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicocele
• Other Study ID Numbers: 49557309-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED