Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design

NCT05113225 | Completed DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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)

Conditions

Assisted Reproductive Technology; Infertility

Keywords

Sperm; micro-swim up; ICSI; Semen processing; density gradient

Outcome Measures

Primary Outcomes (1)

• Number of top quality embryos

  the number of best embryos in each arm in Day 4 or Day 5

  4 or 5 days after ICSI procedure day

Secondary Outcomes (2)

• Early Cleavage rate

  2 days after ICSI procedure day

• chemical pregnancy rate

  14 days after embryo transfer day

Study Arms (2)

DG-ICSI

ACTIVE COMPARATOR

Oocytes of this arm will be injected using sperm previously processed by DG method and located in the commonly used ICSI dishes with the common PVP microdroplets

Procedure: Micro-swim up technique

H pattern-ICSI

EXPERIMENTAL

Oocytes of this arm will be injected using sperm that directly located in a specific H pattern PVP droplets in a commonly used ICSI dishes without pre-processing of the semen

Procedure: Micro-swim up technique

Interventions

Micro-swim up technique PROCEDURE

processing and selection of the sperm for ICSI in the same dish

DG-ICSI; H pattern-ICSI

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age \> 40 years;
• AMH \< 1.0 ng/mL;
• aspirated oocytes \< 8.
• severe male factor
• Testicular aspirated sperm

Sponsors & Collaborators

• Royal Fertility Center, Egypt: lead
• Hawaa Fertility Center: collaborator

Study Sites (1)

Royal Fertility Center

Al Mansurah, Daqahlya, 35511, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Sahar SA Eissa, PHD

  research team leader

  STUDY DIRECTOR

• Engy EA Abdallah, MSC

  investigator & researcher

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 9, 2021
• Study Start: October 10, 2021
• Primary Completion: December 25, 2021
• Study Completion: December 30, 2021
• Last Updated: June 23, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)