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

Primary Purpose

Varicocele

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
microsurgical varicocelectomy in inguinal approach
microsurgical varicocelectomy in subinguinal approach
Sponsored by
Feng Pan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicocele focused on measuring Infertility, varicocelectomy, microsurgery, Chinese men, pregnancy rate

Eligibility Criteria

20 Years - 46 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Primary infertility (more than 1 year)
  2. Serum hormone was normal (FSH, LH, T and PRL)
  3. 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)
  4. All varicocele was diagnosed by physical examination and testified by color Doppler ultrasound
  5. Patients' spouse was healthy in reproduction or had some curable generational diseases

Exclusion Criteria:

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

Sites / Locations

  • Nanjing Maternity and Child Healthcare Hospital Affiliated to Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inguinal group

sub-inguinal group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 26, 2011
Last Updated
April 8, 2013
Sponsor
Feng Pan
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1. Study Identification

Unique Protocol Identification Number
NCT01463787
Brief Title
Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feng Pan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Outcome Measures Before surgery, all patients were diagnosed by physical examination and testified by color Doppler ultrasound. And one trained nurse documented the patients' age, left unilateral or bilateral and the grade of varicocele, and the grade of the more serious side was noted when handled with bilateral ones. During surgery, the duration of surgery was documented. After surgery, a Visual Analogue Scale (VAS) was used to assess the introperative pain after anesthesia recovery and the amount of postoperative pain one month postoperatively by another trained nurse. And the patients whose pain scores > 3 and/or who claimed pain were prescribed with ibuprofen sustained-release capsules (China SmithKline Pharmaceutical Company, Tianjing, China) (0.3g) (ISRC) every 12h on the surgical day (since 2h postoperatively) and only if necessary on the following days (no patient claimed that he had gastrointestinal ulcer history or allergic history of relative drug). Parents were told to write down on a provided form how many times they gave medicine postoperatively. Patients were followed with visits 1 month, 3, 6 and 12 months after surgery, and were encouraged to visit the clinic anytime when they had any complaint in this period. The semen analyses were conducted in the 3, 6 and 12 months in the follow-up. The recurrence or hydrocele formation was testified by color Doppler ultrasound (with/without detected by physical examination) by the same doctor who did the preoperative examination. And this doctor and two nurses mentioned above were all unaware of the patients' groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele
Keywords
Infertility, varicocelectomy, microsurgery, Chinese men, pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inguinal group
Arm Type
Experimental
Arm Title
sub-inguinal group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
microsurgical varicocelectomy in inguinal approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
microsurgical varicocelectomy in subinguinal approach
Intervention Description
In subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring.
Primary Outcome Measure Information:
Title
pregnancy
Description
Postoperative spontaneous pregnancy is considered to be the best indicator to assess fertility status.
Time Frame
within the 12-24 months postoperative period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Nanjing Maternity and Child Healthcare Hospital Affiliated to Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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

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