DNA Damage, Infertility, Male
Conditions
Keywords
Failure to Conceive Due to Infertility of Male Partner, DNA Damage
Brief summary
The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.
Interventions
PROCEDUREIntracytoplasmic sperm injection
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * be considered infertile (\>1 year of unsuccessful attempts of conception * Any race * Male partner with persistent sperm DNA damage, DFI\>=30% * candidates for intracytoplasmic sperm injection (ICSI)
Exclusion criteria
* significant female factor infertility contributing to the couple's infertility * female partner older than 38 years * male or female patients with genetic abnormalities * patients unable or unwilling to give consent after properly informed * couples unsuitable for IVF/ICSI * male patients in whom testicular procedures were contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rates | Up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| birth defects | 1-year following delivery | — |
| sperm DNA damage | Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure | — |
| oocyte fertilization rates | at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI) | — |
| rate of spontaneous abortion | after a clinical pregnancy has been established, up to 10 months after procedure | — |
| blastocyst rate | Day 5 post oocytes retrieval | — |
| pregnancy rate | 6 to 8 week ultrasound | Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound |
| embryo cleavage rate | Day 3 post oocytes retrieval | — |
Outcome results
None listed