Sperm DNA Fragmentation
Conditions
Keywords
SDF, DFI, sperm selection, PICSI, MACS
Brief summary
On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.
Detailed description
Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester. Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates. A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation. In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients
Interventions
Sponsors
The Cleveland Clinic
University of the Western Cape
Ganin Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Males diagnosed of abnormal DNA fragmentation index ( \> 19%). * Males with mild to moderate OTA (oligoteratoasthenozoospermia). * Male aged 18-60 years. * Female aged 18-40 years. * Normo responder ( \> 5 mature oocytes) * Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of oocyte retrieval
Exclusion criteria
Males with normalDNA fragmentation index (\<19%)at the initial assessment. * Leukocytospermia * Presence of varicocele. * Known genetic abnormality * Use of sperm donation or cryopreserved sperm * Use of Oocyte donation * Use of gestational carrier * Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection * Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 20 weeks of gestation | Defined as the proportion of pregnancies that completed more than 20 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of cleavage rate | 3 days | Defined as the proportion of cleaved embryos on day 3 over the injected oocytes |
| Comparison of Blastulation rate | 5-6 days | Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3 |
| Comparison of Blastocyst quality rate | 5-6 days | Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts |
| Comparison of Pregnancy rate | 14 days following embryo transfer | Defined as clinical pregnancy per transfer |
| Comparison of implantation rate | 6- 8 weeks following embryo transfer | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred. |
Countries
Egypt
Outcome results
None listed