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