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Trial registered on ANZCTR


Registration number
ACTRN12612001169831
Ethics application status
Approved
Date submitted
31/10/2012
Date registered
5/11/2012
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The comparison of laparoscopic and microsurgical varicocelectomy on paternity rate 12 months after surgery: a prospective randomized controlled trial
Scientific title
The comparison of laparoscopic and microsurgical varicocelectomy in infertile men with varicocele on paternity rate 12 months after surgery: a prospective randomized controlled trial
Secondary ID [1] 281476 0
Nil
Universal Trial Number (UTN)
U1111-1136-5366
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
male infertility 287735 0
varicocele 287736 0
Condition category
Condition code
Reproductive Health and Childbirth 288077 288077 0 0
Fertility including in vitro fertilisation
Surgery 288098 288098 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
laparoscopic varicocelectomy (standard urologic procedure in infertile patients with varicocele). Transperitoneal (3 trocars 10 mm; 10 mm; 5 mm) approach with ligation of spermatic left vein.
Participants will be observed for a follow-up period of 12 months after completion of surgery. The laparoscopic varicocelectomy surgical procedure takes approximately 30 minutes per participant
Intervention code [1] 285980 0
Treatment: Surgery
Comparator / control treatment
microsurgical subinguinal varicocelectomy (standard urologic procedure in infertile patients with varicocele). Subinguinal approach with ligation of all spermatic veins under 25 x microscopic magnification. Participants will be observed for a follow-up period of 12 months after completion of surgery. The microsurgical subinguinal varicocelectomy takes approximately 90 minutes per participant
Control group
Active

Outcomes
Primary outcome [1] 288283 0
paternity rate - pregnancy test positive twice 2 weeks apart
Timepoint [1] 288283 0
12 month after surgery
Secondary outcome [1] 299754 0
1.Semen analysis (1. Semen volume 2. Total sperm number 3. sperm concentration 4. Sperm motility 5. Sperm progressive motility 6. vitality 7. Sperm morphology)
Timepoint [1] 299754 0
a. before admission to hospital (oligo/asteno/terato zoospermia confirmed)
b. 3 months after surgery
c. 6 months after surgery
d. 12 months after surgery
Secondary outcome [2] 299755 0
2.FSH (foliculotropic hormone) - ELISA method
Timepoint [2] 299755 0
a. Before admission to hospital
b. 6 months after surgery
c. 12 months after surgery
Secondary outcome [3] 299756 0
3.LH (luteotropic hormone) - ELISA method
Timepoint [3] 299756 0
a. Before admission to hospital
b. 6 months after surgery
c. 12 months after surgery
Secondary outcome [4] 299757 0
4.Prolactin- ELISA method
Timepoint [4] 299757 0
a. Before admission to hospital
b. 6 months after surgery
c. 12 months after surgery
Secondary outcome [5] 299758 0
5.Testosterone- ELISA method
Timepoint [5] 299758 0
a. Before admission to hospital
b. 6 months after surgery
c. 12 months after surgery
Secondary outcome [6] 299759 0
6.IIEF - International index for erectile function
Timepoint [6] 299759 0
a. Before surgery
b. 6 monts after
c. 12 months after
Secondary outcome [7] 299760 0
7.USG (ultrasound examination of testis)
Timepoint [7] 299760 0
a. testicular volume
i. Before admission to hospital (confirmation of varicocele in Doppler)
ii. 12 months after surgery
b. Left spermatic vein diameter (if both sides varicocele - average vein diameter of left and right spermatic vein) in standing position
i. Before admission to hospital
ii. 12 months after surgery

Eligibility
Key inclusion criteria
a. Palpable varicocele (no subclinical) one or both sides
b. Infertility (primary and secondary) over 12 months
c. Oligozoospermia (<15 mln/ml) or astenozoospermia (<32%) or teratozoospermia (<4%) in semen analysis
d. Male factor (healthy women)
e. No other cause of infertility in men
f. Normal TSH
Minimum age
18 Years
Maximum age
40 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
a. Azoospermia
b. Recurrent varicocele
c. Undescended testis
d. Mumps
e. Secondary hypogonadism
f. Hyperprolactynemia
g. Testosterone/antiestrogen therapy
h. Age over 40
i. History of testis cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
simple randomization (sealed opaque envelopes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization list - statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4661 0
Poland
State/province [1] 4661 0
Silesia

Funding & Sponsors
Funding source category [1] 286242 0
Self funded/Unfunded
Name [1] 286242 0
Address [1] 286242 0
Country [1] 286242 0
Poland
Primary sponsor type
Individual
Name
Piotr Bryniarski
Address
3 Maja street 13-15,
41-800 Zabrze,
Country
Poland
Secondary sponsor category [1] 285065 0
None
Name [1] 285065 0
Address [1] 285065 0
Country [1] 285065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288322 0
Ethics Committee of Medical University of Silesia
Ethics committee address [1] 288322 0
Poniatowskiego Street 15,
40-055 Katowice, Silesia
Ethics committee country [1] 288322 0
Poland
Date submitted for ethics approval [1] 288322 0
01/06/2012
Approval date [1] 288322 0
25/09/2012
Ethics approval number [1] 288322 0

Summary
Brief summary
This is a comperative study of two surgical interventions in infertile men with varicocele. Both interventions are widely accepted, but only retrospective studies proved their equivalence. In our opinion microsurgical intervention is superior both in terms of safety and efficacy. The only good comparison may be done in a prospective manner.
Trial website
Trial related presentations / publications
As the follow-up ended in december 2015 we have not presented our study to anyone yet.
Public notes

Contacts
Principal investigator
Name 34899 0
Dr Piotr Bryniarski
Address 34899 0
Department of Urology, Medical University of Silesia in Katowice, 3 MAJA Street 13-15. 41-800 Zabrze, Poland
Country 34899 0
Poland
Phone 34899 0
+48 605611963
Fax 34899 0
Email 34899 0
piotr.bryniarski@hotmail.com
Contact person for public queries
Name 18146 0
Dr Piotr Bryniarski
Address 18146 0
3 Maja street 13-15
41-800, Zabrze
Country 18146 0
Poland
Phone 18146 0
0048323704454
Fax 18146 0
Email 18146 0
piotr.bryniarski@neostrada.pl
Contact person for scientific queries
Name 9074 0
Dr Piotr Bryniarski
Address 9074 0
3 Maja street 13-15
41-800, Zabrze
Country 9074 0
Poland
Phone 9074 0
0048323704454
Fax 9074 0
Email 9074 0
piotr.bryniarski@neostrada.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary