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Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Density Gradient Centrifugation (DGC) | Other | Using the routine DGC sperm processing only |
|
| Physiological ICSI (PICSI) | Active Comparator | Using PICSI dish for selecting sperm with lower sperm DNA fragmentation |
|
| Magnetic Activated Cell Sorting (MACS) | Active Comparator | Using MACS for selecting sperm with lower sperm DNA fragmentation |
|
| Testicular sperm (Testi) | Active Comparator | Using testicular sperm not ejaculated sperm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Density Gradient Centrifugation | Other | Semen processing is done by double layer density gradient method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Defined as clinical pregnancy per transfer | 14 days following embryo transfer |
| Implantation rate | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred. | 6- 8 weeks following embryo transfer |
| Ongoing pregnancy rate | Defined as the proportion of pregnancies that completed more than 20 weeks of gestation | 20 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eman Hasanen | Ganin Fertility Center | Principal Investigator |
| khaled Elqusi | Ganin Fertility Center | Principal Investigator |
| Salma Eltanbouly | Ganin Fertility Center | Principal Investigator |
| Samar Gamal | Ganin Fertility Center | Principal Investigator |
| Abd ElGhafar Hussin | Ganin Fertility Center | Principal Investigator |
| Hanaa Elkhadr | Ganin Fertility Center | Principal Investigator |
| Hosam Zaki | Ganin Fertility Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganin Fertility Center | Cairo | Maadi | 1728 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34076869 | Derived | Hozyen M, Hasanen E, Elqusi K, ElTanbouly S, Gamal S, Hussin AG, AlKhader H, Zaki H. Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients with Abnormal Sperm DNA Fragmentation: a Randomized Controlled Trial. Reprod Sci. 2022 Jan;29(1):220-228. doi: 10.1007/s43032-021-00642-y. Epub 2021 Jun 2. |
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| Physiological ICSI | Other | Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head |
|
|
| Magnetic activated cell sorting | Other | Sperm selection by using Annexin V micro-beads and separation columns |
|
|
| Testicular sperm | Other | Using testicular sperm retrieved by TESA or TESE |
|
|
| 5-6 days |
| High quality blastocyst 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 |
| Miscarriage rate | Defined as the proportion of miscarried cases | 20 weeks of gestation |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002499 | Centrifugation, Density Gradient |
| D053625 | Sperm Retrieval |
| ID | Term |
|---|---|
| D014461 | Ultracentrifugation |
| D002498 | Centrifugation |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D020858 | Tissue and Organ Harvesting |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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