Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

NCT ID: NCT02695199

Last Updated: 2016-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Varicocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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laparoscopic varicocelectomy

laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group

Group Type EXPERIMENTAL

Laparoscopic varicocelectomy

Intervention Type PROCEDURE

Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound

microscopic varicocelectomy

conventional Microscopic Subinguinal varicocelectomy group

Group Type SHAM_COMPARATOR

Microscopic Subinguinal varicocelectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic varicocelectomy

Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound

Intervention Type PROCEDURE

Microscopic Subinguinal varicocelectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic varicocelectomy assisted by Doppler ultrasound Traditional microscopic Subinguinal varicocelectomy

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mingzhen Yuan, MD

Role: STUDY_DIRECTOR

Second hospital of Shandong University

Locations

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Second Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengtian Zhao, PHD

Role: CONTACT

+86053185875401

Facility Contacts

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Mingzhen Yuan, PHD

Role: primary

+8615053155899

Liqiang Guo, MD

Role: backup

+8618253132651

Other Identifiers

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49557309-6

Identifier Type: -

Identifier Source: org_study_id

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