Assisted Reproductive Technology, Infertility
Conditions
Keywords
Sperm, micro-swim up, ICSI, Semen processing, density gradient
Brief summary
A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique)
Detailed description
In This study investigators compare a novel sperm processing and selection method which is (fast, cheap and safe) with the well known processing method of sperm Density gradient (DG) The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10 μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid with mineral oil. Control group : Oocytes will be injected using sperm after processing with DG and will be selected from control PVP microdroplets Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP microdroplets is prepared on H Pattern and will be selected from the far point from the deposition point and will be injected into the oocytes from the sample group All injected MII oocytes from both groups will then be cultured, with each group demarcated in separate place in the culture dish then according to the randomisation embryo transfer will be selected from one of both groups then the quality of the embryos will be reported and the pregnancy rate
Interventions
PROCEDUREMicro-swim up technique
processing and selection of the sperm for ICSI in the same dish
Sponsors
Hawaa Fertility Center
Royal Fertility Center, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
the oocytes of each patient will be randomly divided before denudation and will be distributed in the ICSI dishes of different previously described PVP pattern and sperm processing
Intervention model description
Single group of patients will be recruited in the study and each patient's oocytes will be divided into two groups and each group of patients will be injected with sperm processed by normal DG or H pattern micro- swim up technique. The PVP was used to produce the H pattern (length of about 2 cm from one side of the plate to the middle of the disk, total volume 10 μL). A small amount of semen (3 μL) was placed on one side of the H, and some time was allowed for it to migrate to the other side where the sperm was then collected. The dishes were incubated for three minutes allowing sperm migration along the outer perimeter of the H. After the completion of sperm migration, the plate was turned before the upload to avoid the contamination of the injection pipette by the sample.The injection pipette was introduced into the H-ICSI™ and used to immobilize a single sperm by crushing the membrane of its tail.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* The normal & high responders were selected according to : * age: 18 - 40 years * anti-Müllerian hormone (AMH): \> 1.0 ng/ml * number of aspirated oocytes:more than or equal 8 * BMI \< 34
Exclusion criteria
* Age \> 40 years; * AMH \< 1.0 ng/mL; * aspirated oocytes \< 8. * severe male factor * Testicular aspirated sperm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of top quality embryos | 4 or 5 days after ICSI procedure day | the number of best embryos in each arm in Day 4 or Day 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Cleavage rate | 2 days after ICSI procedure day | The early cleavage rate of oocytes from overall injected oocytes |
| chemical pregnancy rate | 14 days after embryo transfer day | the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases |
Countries
Egypt
Outcome results
None listed