One side versus both side surgery for infertile patients having no sperms in semen

Recruiting

Conditions: Azoospermia, Idiopathic obstructive Azoospermia,

Registration Number: CTRI/2019/08/020934

Lead Sponsor: AIIMS

Brief Summary: Infertility affects 15% of couples in the reproductive age group and the male factors account for about 50% of infertility. Obstruction in the ductal system is one of the treatable causes of azoospermia and microsurgical reconstruction is recommended for obstructions in the vas deferens and epididymis. If epididymal obstruction is present, whether as a primary pathology or as secondary to infection or inflammation, a vasoepididymostomy (VE) is required proximal to the obstruction to restore continuity of sperm transport. Unilateral surgery is associated with lower operative time and complications. Unilateral surgery also preserves the contralateral epididymis for sperm retrieval in case of failure of anastomosis. However, a post-hoc, sub group analysis of our previous data on VE suggested that bilateral VE maybe associated with higher success.

Hypothesis

Bilateral vaso -epididymal anastomosis has better patency rates than unilateral surgery amongst men with idiopathic obstructive azoospermia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 70

Inclusion Criteria

1.Clinical examination on patients excluded bilateral vas aplasia.
Normal semen volume, presence of fructose and absolute azoospermia was conï¬rmed on at least two semen samples.
No patient had had a previous vasectomy, inguinal or scrotal surgery, trauma, or inï¬‚ammation/infection of the testis.
Fine-needle (23 G) aspiration cytology was performed on both testes, the aspirate was stained with Giemsa stain and considered to show â€˜normalâ€™ spermatogenesis if the slide revealed many mature sperm 2.Both sides are suitable for surgery 3.Patient willing for bilateral surgery if the randomization chart places him in the bilateral category.

Exclusion Criteria

1.Patients with previous failed vaso- epididymal anastomosis 2.Patients who, during surgery, are found to be not suitable for reconstruction or where the surgery is abandoned.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Patency rate (determined by appearance of sperm in the ejaculate), complication rate and operative time after unilateral versus bilateral Vaso-epididymal anastomosis	Patients will be asked to maintain sexual abstinence for 6 weeks. Semen analysis will be done at 6 weeks following surgery followed by repeat analysis at 12 weeks and then at every subsequent 3 months intervals for a follow up period of 12 months or till sperm are seen in the ejaculate, whichever is earlier

Secondary Outcome Measures

Name	Time	Method
1.Comparison of patients characteristics (age, duration of infertility, FSH and epididymal sperm motility) between the two groups	At the time of randomization
2.Identify factors among bilateral surgery patients which suggest better patency than unilateral surgery	At the time of enrollment