Biobanking of a testis biopsy from men with azoospermia who undergo a TESE procedure to allow investigation for understanding the etiology of male infertility, research about normal and aberrant male gamete formation in its natural environment of…
ID
Source
Brief title
Condition
- Testicular and epididymal disorders
Synonym
Sponsors and support
Intervention
Outcome measures
Primary outcome
To biobank testis biopsies in order to investigate all aspects of the process
of human sperm production and defects in sperm production in patients with a
sever male factor.
Secondary outcome
- To understand the cellular and molecular aspects of male infertility
- To develop novel treatment strategies for male infertility
Background summary
Subfertility affects approximately 15% of all couples, and a severe male factor
is identified in 17% of these couples. The etiology of a severe male factor
remains largely unknown. Couples with a severe male factor can resort to
intracytoplasmic sperm injection (ICSI), with either ejaculated spermatozoa (in
case of oligozoospermia) or surgically retrieved testicular spermatozoa (TESE)
(in case of azoospermia) to generate biologically own children. However,
currently there is no direct treatment for men with azoospermia or
oligozoospermia. However to get a better understanding about the etiology of
male infertility, research about normal and aberrant male gamete formation in
its natural environment of the testis is necessary to pave the way to establish
future interventions.
Study objective
Biobanking of a testis biopsy from men with azoospermia who undergo a TESE
procedure to allow investigation for understanding the etiology of male
infertility, research about normal and aberrant male gamete formation in its
natural environment of the testis is necessary to pave the way to establish
future interventions.
Study design
Men with azoospermia that have a wish for biologically own children can opt to
undergo a TESE procedure to obtain testicular sperm in order to fertilize an
oocyte during a subsequent IVF procedure. From those infertile patients who
undergo a TESE procedure, we like to obtain an additional testis biopsy with
informed consent for storage in the 'AMC Biobank Reproduction And Development'.
Study burden and risks
Taking an additional biopsy will not do any harm to the remaining testis or has
consequences for the health of the men as this additional biopsy is taken
during the standard TESE procedure.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
all adult men ondergoing TESE procedure.
Exclusion criteria
- HIV positive men
- patients who do not want to be informed in case of an unexpected negative finding related to a treatable or preventable disease that is clinically relevant for this men or his family.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58218.000.16 |