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The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay May Improve ICSI Outcome.

The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06156722
Enrollment
189
Registered
2023-12-05
Start date
2019-03-01
Completion date
2024-02-01
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Issues

Keywords

IMSI, SpermSlow, Sperm selection, ICSI outcome, Sibling-oocytes study

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.

Interventions

PROCEDURESperm selection by IMSI

Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI)

PROCEDURESperm selection by IMSI and spermslow

Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow

Sponsors

Assuta Medical Center
CollaboratorOTHER
Tel Aviv University
CollaboratorOTHER
Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pregnancy and delivery ratesWithin up to 10 month from treatmentPregnancy and delivery rates

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026