To evaluate the efficacy of TESE and to describe the risks of the TESE procedure for the men with a four year follow-up of their offspring.
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
- Genitourinary tract disorders NEC
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Percentage congenital malformations, neurological- and behaviour problems in
children born after TESE
Secondary outcome
- The percentage of TESE procedures in which usuable spermatozoa are found (the
sperm retrieval rate [SRR])
- The number of ICSI procedures per TESE
- The fertilization rate
- Clinical pregnancy per patient with a azoospermia
- Ongoing pregnancy rate per patient with a azoospermia
- Ongoing pregnancies per TESE procedure
- Number of life births per TESE
- Clinical pregnancy rate per ICSI cycle
- Ongoing pregnancy rate per ICSI cycle
- Miscarriage rate per ICSI cycle
- Complications after TESE: infection, bleeding, pain and decrease of
testosterone level
Background summary
Testicular sperm extraction (TESE) in combination with intracytoplasmatic sperm
injection (ICSI) is the only way that men with a non obstructive azoospermia
(NOA) or obstructive azoospermia (OA) which cannot be repaired or treated by
means of PESA/MESA can get their own offspring. Data on the efficacy in
generating pregnancies and the safety regarding side effects for the man and
possible offspring are not well described.
Study objective
To evaluate the efficacy of TESE and to describe the risks of the TESE
procedure for the men with a four year follow-up of their offspring.
Study design
A prospective observational cohort study.
Study burden and risks
Men:
- To undergo testicular biopsies with a risk of bleeding, infection, pain and
decrease of testosteron.
- A scrotal ultrasound
- Bloodwithdrawal twice to check hormones
- The psychological burden: the chance of no sperm retrieval at all, ICSI
failures
Women: ICSI procedure
Children undergo a physical and neurological examination at the age of five
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Azoospermia, trying to conceive
Exclusion criteria
Contraindication for ICSI treatment
Design
Recruitment
Medical products/devices used
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 | NL12408.000.06 |