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

December 17, 2023 updated by: Yael Yagur, Meir Medical Center

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The IMSI-only group
Procedure: Sperm selection by IMSI
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI)
Active Comparator: IMSI with SpermSlow group
Procedure: Sperm selection by IMSI and spermslow
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow
No Intervention: Mixed embryo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy and delivery rates
Time Frame: Within up to 10 month from treatment
Pregnancy and delivery rates
Within up to 10 month from treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Tel Aviv University
Assuta Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEIRIMSIRCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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