Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

Not Applicable

• Conditions: Varicocele
• Interventions: Procedure: Laparoscopic varicocelectomy; Procedure: Microscopic Subinguinal varicocelectomy

• Registration Number: NCT02695199
• Lead Sponsor: The Second Hospital of Shandong University

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.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-01
• Last Update Posted: 2016-03-01
• Primary Completion: 2017-01
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic varicocelectomy	Laparoscopic varicocelectomy	laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group
microscopic varicocelectomy	Microscopic Subinguinal varicocelectomy	conventional Microscopic Subinguinal varicocelectomy group

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	The pregnancy rate was calculated at 1 year of follow-up

Secondary Outcome Measures

Name	Time	Method
semen quality assessment	semen quality assessment were checked at 3, 6 and 12 months after surgery.	Routine sperm quality check including Count，Morphology and Motility using both the conventional manual method and computer assisted sperm analysis (CASA) systems.
postoperative complications	postoperative complications at 3, 6 and 12 months after surgery

Trial Locations

Locations (1)

Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China