Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

NCT02695199 | Unknown DMC

• 1 other identifier: 49557309-6
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicocele

Keywords

Doppler Ultrasound; Laparoscopic; Microscopic Subinguinal Varicocelectomy

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

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

Secondary Outcomes (2)

• semen quality assessment

  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

Study Arms (2)

laparoscopic varicocelectomy

EXPERIMENTAL

laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group

Procedure: Laparoscopic varicocelectomy

microscopic varicocelectomy

SHAM COMPARATOR

conventional Microscopic Subinguinal varicocelectomy group

Procedure: Microscopic Subinguinal varicocelectomy

Interventions

Laparoscopic varicocelectomy PROCEDURE

Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound

Also known as: Laparoscopic varicocelectomy assisted by Doppler ultrasound

laparoscopic varicocelectomy

Microscopic Subinguinal varicocelectomy PROCEDURE

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

Also known as: Traditional microscopic Subinguinal varicocelectomy

microscopic varicocelectomy

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mingzhen Yuan, MD

  Second hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Shengtian Zhao, PHD

CONTACT

+86053185875401; 398139849@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: March 1, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 1, 2016

Record last verified: 2016-01

Locations

CN (1)