The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay May Improve ICSI Outcome.
1 other identifier
interventional
189
1 country
1
Brief Summary
In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes. The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS). The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedDecember 19, 2023
December 1, 2023
4.9 years
November 2, 2023
December 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy and delivery rates
Pregnancy and delivery rates
Within up to 10 month from treatment
Study Arms (3)
The IMSI-only group
ACTIVE COMPARATORThe IMSI-only group
IMSI with SpermSlow group
ACTIVE COMPARATORIMSI with SpermSlow group
Mixed embryo group
NO INTERVENTIONMixed embryo group
Interventions
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI)
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow
Eligibility Criteria
You may qualify if:
- females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples
You may not qualify if:
- frozen embryos surgically extracted sperm preparations embryo-biopsy cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meir Medical Centerlead
- Assuta Medical Centercollaborator
- Tel Aviv Universitycollaborator
Study Sites (1)
Meir Medical Center
Kfar Saba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, Obstetrics and Gynaecology Department. Principal investigator. Lecturer.
Study Record Dates
First Submitted
November 2, 2023
First Posted
December 5, 2023
Study Start
March 1, 2019
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
December 19, 2023
Record last verified: 2023-12