The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Meir Medical Center
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Pregnancy and delivery rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 38 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples
Exclusion Criteria
- •frozen embryos surgically extracted sperm preparations embryo-biopsy cycles
Arms & Interventions
The IMSI-only group
The IMSI-only group
Intervention: Sperm selection by IMSI (Procedure)
IMSI with SpermSlow group
IMSI with SpermSlow group
Intervention: Sperm selection by IMSI and spermslow (Procedure)
Mixed embryo group
Mixed embryo group
Outcomes
Primary Outcomes
Pregnancy and delivery rates
Time Frame: Within up to 10 month from treatment
Pregnancy and delivery rates
Secondary Outcomes
No secondary outcomes reported
Investigators
Yael Yagur
Consultant, Obstetrics and Gynaecology Department. Principal investigator. Lecturer.
Meir Medical Center