Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

T

The Second Hospital of Shandong University

Status

Unknown

Conditions

Varicocele

Treatments

Procedure: Laparoscopic varicocelectomy
Procedure: Microscopic Subinguinal varicocelectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02695199
49557309-6

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

20 to 39 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

laparoscopic varicocelectomy
Experimental group
Description:
laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy group
Treatment:
Procedure: Laparoscopic varicocelectomy
microscopic varicocelectomy
Sham Comparator group
Description:
conventional Microscopic Subinguinal varicocelectomy group
Treatment:
Procedure: Microscopic Subinguinal varicocelectomy

Trial contacts and locations

1

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Central trial contact

Shengtian Zhao, PHD

Data sourced from clinicaltrials.gov

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