Clinical trial NCT05113225: Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
Official title: Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assisted Reproductive Technology
Infertility
Keywords: Sperm
micro-swim up
ICSI
Semen processing
density gradient
Lead sponsor: Royal Fertility Center, Egypt
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2021-11-09
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of top quality embryos
timeFrame: 4 or 5 days after ICSI procedure day
Secondary outcomes:
measure: Early Cleavage rate
timeFrame: 2 days after ICSI procedure day
measure: chemical pregnancy rate
timeFrame: 14 days after embryo transfer day
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Royal Fertility Center
state: Daqahlya
Study officials:
affiliation: research team leader
name: Sahar SA Eissa, PHD
role: STUDY_DIRECTOR
affiliation: investigator & researcher
name: Engy EA Abdallah, MSC
role: STUDY_CHAIR
References: