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Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

Primary Purpose

Varicocele

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Laparoscopic varicocelectomy

Microscopic Subinguinal varicocelectomy

About this trial

This is an interventional treatment trial for Varicocele focused on measuring Doppler Ultrasound, Laparoscopic, Microscopic Subinguinal Varicocelectomy

Eligibility Criteria

20 Years - 39 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;
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;
with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;
patient's spouse was healthy in reproduction.

Exclusion Criteria:

with subclinical varicocele, recurrent varicoceles;
normal semen analyses;
other reasons of infertility than varicoceles;
refusing to enter randomization;
female partner older than 35 years;
with abnormal level of serum hormones;
female factor infertility;
with significant surgical diseases, congenital diseases or endocrine diseases.

Sites / Locations

Second Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

laparoscopic varicocelectomy

microscopic varicocelectomy

Arm Description

laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group

conventional Microscopic Subinguinal varicocelectomy group

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

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.

postoperative complications

Full Information

NCT ID

NCT02695199

First Posted

January 21, 2016

Last Updated

February 29, 2016

Sponsor

The Second Hospital of Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT02695199

Brief Title

Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Hospital of Shandong University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicocele

Keywords

Doppler Ultrasound, Laparoscopic, Microscopic Subinguinal Varicocelectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

laparoscopic varicocelectomy

Arm Type

Experimental

Arm Description

laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group

Arm Title

microscopic varicocelectomy

Arm Type

Sham Comparator

Arm Description

conventional Microscopic Subinguinal varicocelectomy group

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic varicocelectomy

Other Intervention Name(s)

Laparoscopic varicocelectomy assisted by Doppler ultrasound

Intervention Description

Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound

Intervention Type

Procedure

Intervention Name(s)

Microscopic Subinguinal varicocelectomy

Other Intervention Name(s)

Traditional microscopic Subinguinal varicocelectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

Pregnancy rate

Time Frame

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

Secondary Outcome Measure Information:

Title

semen quality assessment

Description

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.

Title

postoperative complications

Time Frame

postoperative complications at 3, 6 and 12 months after surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles; 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; with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin; patient's spouse was healthy in reproduction. Exclusion Criteria: with subclinical varicocele, recurrent varicoceles; normal semen analyses; other reasons of infertility than varicoceles; refusing to enter randomization; female partner older than 35 years; with abnormal level of serum hormones; female factor infertility; with significant surgical diseases, congenital diseases or endocrine diseases.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shengtian Zhao, PHD

Phone

+86053185875401

398139849@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhen Yuan, MD

Organizational Affiliation

Second hospital of Shandong University

Official's Role

Study Director

Facility Information:

Facility Name

Second Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250033

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingzhen Yuan, PHD

Phone

+8615053155899

yuanmingzhen2005@126.com

First Name & Middle Initial & Last Name & Degree

Liqiang Guo, MD

Phone

+8618253132651

glq_66@yeah.net

First Name & Middle Initial & Last Name & Degree

Liqiang Guo, MD

First Name & Middle Initial & Last Name & Degree

Wendong Sun, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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