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NCT06156722 Clinical Trial

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

Fertility Issues Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06156722
Other study ID # MEIRIMSIRCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date February 1, 2024

Study information
Verified date December 2023
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 189
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Sperm selection by IMSI
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI)
• Sperm selection by IMSI and spermslow
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (3)
Lead Sponsor Collaborator
Meir Medical Center Assuta Medical Center, Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy and delivery rates Pregnancy and delivery rates Within up to 10 month from treatment
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