Status:
COMPLETED
Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial
Lead Sponsor:
Feng Pan
Conditions:
Varicocele
Eligibility:
MALE
20-46 years
Phase:
PHASE4
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 s...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01463787
Start Date
January 1 2009
End Date
December 1 2010
Last Update
April 10 2013
Active Locations (1)
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1
Nanjing Maternity and Child Healthcare Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210004