Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

Varicocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02695199
• Other study ID #: 49557309-6
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: February 29, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: The Second Hospital of Shandong University
• Contact: Shengtian Zhao, PHD
• Phone: +86053185875401
• Email: 398139849[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Shandong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicocele

Intervention

Procedure:
• Laparoscopic varicocelectomy
Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound
• Microscopic Subinguinal varicocelectomy
Infertile patients with clinically palpable varicoceles were selected to receive microscopic Subinguinal varicocelectomy

Locations

Country	Name	City	State
China	Second Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		The pregnancy rate was calculated at 1 year of follow-up	No
Secondary	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.	Yes
Secondary	postoperative complications		postoperative complications at 3, 6 and 12 months after surgery	Yes