Infertility, Male
Conditions
Keywords
Sperm DNA fragmentation, PICSI, MACS, Sperm Selection, DGC
Brief summary
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.
Interventions
Semen processing is done by double layer density gradient method.
OTHERPhysiological ICSI
Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head
Sperm selection by using Annexin V micro-beads and separation columns
OTHERTesticular sperm
Using testicular sperm retrieved by TESA or TESE
Sponsors
Ganin Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female age was ≤37 years * Female should has 5≥ metaphase II oocytes * Males having abnormal SDF levels ≥ 20.3% by TUNEL assay * Abstinence from 1 to 2 days * Males having at least 1 million total motile progressive count
Exclusion criteria
* 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 |
|---|---|---|
| Clinical pregnancy rate | 14 days following embryo transfer | Defined as clinical pregnancy per transfer |
| 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. |
| 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 |
|---|---|---|
| Cleavage rate | 3 days | Defined as the proportion of cleaved embryos on day 3 over the injected oocytes |
| Miscarriage rate | 20 weeks of gestation | Defined as the proportion of miscarried cases |
| Blastulation rate | 5-6 days | Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3 |
| High quality blastocyst 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