| CTRI Number |
CTRI/2019/08/020934 [Registered on: 28/08/2019] Trial Registered Retrospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
One side versus both side surgery for infertile patients having no sperms in semen |
|
Scientific Title of Study
|
Bilateral versus unilateral vaso - epididymostomy in patients with idiopathic obstructive azosspermia: A prospective randomized trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room No 5030 Department of Urology
AIIMS,
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
rajeev02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room No 5030 Department of Urology
AIIMS,
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
rajeev02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Gurnani |
| Designation |
MCH UROLOGY STUDENT |
| Affiliation |
AIIMS |
| Address |
Room No 5030 Department of Urology
AIIMS,
New Delhi
South
DELHI
110029
India |
| Phone |
9868037546 |
| Fax |
|
| Email |
nishant.gurnani@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Rajeev Kumar |
AIIMS |
Department oF Urology
AIIMS
Ansari Nagar
South
DELHI |
9868397435
rajeev02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N460||Azoospermia, Idiopathic obstructive Azoospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Vaso-epididymostomy |
Vaso-epididymostomy is a standrad operation for patients with Idiopathic obstructive azoospermia. It will be done on bilateral vas deferens in patients |
| Comparator Agent |
Unilateral vaso-epididymostomy |
Vaso-epididymostomy is a standard operation for patients with idiopathic obstructive azoospermia. It will be done unilaterally in randomized patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
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 inflammation/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 ‘normal’ 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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Publicated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |