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

Not Applicable

Active, not recruiting

• Conditions: Fertility Issues

• Registration Number: NCT06156722
• Lead Sponsor: Meir Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-26
• Status Verified: 2023-12
• Study First Posted: 2023-12-05
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 189

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pregnancy and delivery rates	Within up to 10 month from treatment	Pregnancy and delivery rates

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel