Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial

NCT01463787 | Completed Phase 4 DMC

• 1 other identifier: FPan
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Varicocele is the most common surgical disease which could lead to male infertility. It is found in approximately 15% adult males, and in about 40% infertile males. And the incidence is up to 80% in secondary infertility. In the past, there was continuous controversy over whether a varicocele repair could improve fertility. But at present, researches are coming to a consensus on the indication of varicocelectomy. Several researches manifest that the microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and lowest complications rate after surgery. Microsurgical varicocelectomy includes two approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There are few studies which make direct comparison between the two methods in microsurgical varicocelectomy, especially in China. Operators have made decisions on the basis of their own experience and skills. In this study, the investigators compare the postoperative spontaneous pregnancy and complications rates in two approaches in microsurgical varicocelectomy for Chinese infertile men in their hospital.

Conditions

Varicocele

Keywords

Infertility; varicocelectomy; microsurgery; Chinese men; pregnancy rate

Outcome Measures

Primary Outcomes (1)

• pregnancy

  Postoperative spontaneous pregnancy is considered to be the best indicator to assess fertility status.

  within the 12-24 months postoperative period

Study Arms (2)

inguinal group

EXPERIMENTAL

Procedure: microsurgical varicocelectomy in inguinal approach

sub-inguinal group

ACTIVE COMPARATOR

Procedure: microsurgical varicocelectomy in subinguinal approach

Interventions

microsurgical varicocelectomy in inguinal approach PROCEDURE

In inguinal approach, the incision, which was about 3cm, was made two fingers up the pubic symphysis, from external inguinal rings parallel to the inguinal ligament.

inguinal group

microsurgical varicocelectomy in subinguinal approach PROCEDURE

In subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring.

sub-inguinal group

Eligibility Criteria

• Age: 20 Years - 46 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary infertility (more than 1 year)
• Serum hormone was normal (FSH, LH, T and PRL)
• Semen analysis which was taken within 3-7 days of abstinence was abnormal for at least twice, and at least 1 month apart (the value of sperm density was less than 20 million per ml, and/or sperm motility a+b was less than 50%, according to the 4th WHO criteria)
• All varicocele was diagnosed by physical examination and testified by color Doppler ultrasound
• Patients' spouse was healthy in reproduction or had some curable generational diseases

You may not qualify if:

• Secondary infertility
• Men with subclinical varicocele or normal semen analyses
• Having some other surgical diseases, such as genital tract infection or deformity
• Having some congenital diseases, such as Klinefelter and Y chromosome deficiency
• Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on
• Patients' spouse had some diseases that made them unable to carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.

Sponsors & Collaborators

• Feng Pan: lead

Study Sites (1)

Nanjing Maternity and Child Healthcare Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Varicocele; Infertility

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Attending Doctor

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: November 2, 2011
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

CN (1)