Male Infertility
Conditions
Keywords
intracytoplasmic sperm injection, Male infertility, apoptosis, flow cytometry and sorting, DNA fragmentation
Brief summary
In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.
Interventions
PROCEDUREStaining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS
PROCEDURESwim-up
Semen processing will be carried out with the conventional swim-up method.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* infertile couples needing treatment with ICSI * male infertility as defined by the WHO 2010 criteria * age of the treated women should be between 22 and 39 years of age. * normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l. * signed consent form.
Exclusion criteria
* normal male infertility, as defined by the WHO 2010 criteria * age of the treated women below 22 years and above 39 years * reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration. * Not more than two preceding unsuccessfull treatments with ICSI * Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness. * Participation in another study. * lack of a signed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate | Week 12 of gestation |
Secondary
| Measure | Time frame |
|---|---|
| Number of diploidic fertilized oocytes. | one day after intracytoplasmic sperm injection |
Other
| Measure | Time frame |
|---|---|
| Number of embryos growing to the blastocyst stage | 5 days after intracytoplasmic sperm injection |
| Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred | week 12 of gestation |
Countries
Switzerland
Outcome results
None listed