Male Infertility
Conditions
Keywords
Sperm DNA fragmentation, Second ejaculate, Sperm Selection, PICSI
Brief summary
Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.
Detailed description
Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.
Interventions
OTHERSecond ejaculate
Semen processing by density gradient centrifugation for the second ejaculate
DEVICEPICSI
Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
Sponsors
Ganin Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Male partner with abnormal sperm DNA fragmentation index (\>20%) by TUNEL assay * Male partner with at least 1 million progressive motile count * Male aged 18-50 years * Male with adjusted sexual abstinence days (1-2 days) * Female aged 18-37 years * Normo-responder females (at least 5 mature oocytes)
Exclusion criteria
* Leukocytospermia * Varicocele * Known genetic abnormality * Use of oocyte or sperm donors * Use of a gestational carrier * Presence of any endometrial factors that can affect embryo implantation * Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization rate | 16-19 hours | Defined as the proportion of fertilized oocytes over the injected oocytes. |
| Cleavage rate | 3 days | Defined as the proportion of cleaved embryos on day 3 over the injected oocytes. |
| Blastulation rate | 5-6 days | Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3. |
| 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. |
Countries
Egypt
Outcome results
None listed