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Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal SDF | No Intervention | Using routine semen processing method | |
| Physiological ICSI (PICSI) | Active Comparator | Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI |
|
| Second ejaculate | Active Comparator | Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICSI | Device | Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | Defined as the proportion of fertilized oocytes over the injected oocytes. | 16-19 hours |
| Cleavage rate | Defined as the proportion of cleaved embryos on day 3 over the injected oocytes. | 3 days |
| Blastulation rate | Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3. | 5-6 days |
| Blastocyst quality rate | 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. | 5-6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eman Hasanen | Ganin Fertility Center | Principal Investigator |
| Radwa Omar | Ganin Fertility Center | Principal Investigator |
| Hanaa Alkhader | Ganin Fertility Center | Principal Investigator |
| Hosam Zaki, MSc, FRCOG | Ganin Fertility Center | Study Director |
| Manar Hozayen, MSc. | Ganin Fertility Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganin Fertility Center | Cairo | Cairo Governorate | 11728 | Egypt |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| Second ejaculate | Other | Semen processing by density gradient centrifugation for the second ejaculate |
|
| D052801 |
| Male Urogenital Diseases |