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

NCT ID: NCT06156722

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2024-02-01

Brief Summary

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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

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Conditions

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Fertility Issues

Keywords

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IMSI SpermSlow Sperm selection ICSI outcome Sibling-oocytes study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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The IMSI-only group

The IMSI-only group

Group Type ACTIVE_COMPARATOR

Sperm selection by IMSI

Intervention Type PROCEDURE

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

IMSI with SpermSlow group

IMSI with SpermSlow group

Group Type ACTIVE_COMPARATOR

Sperm selection by IMSI and spermslow

Intervention Type PROCEDURE

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

Mixed embryo group

Mixed embryo group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sperm selection by IMSI

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assuta Medical Center

OTHER

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yael Yagur

Consultant, Obstetrics and Gynaecology Department. Principal investigator. Lecturer.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MEIRIMSIRCT

Identifier Type: -

Identifier Source: org_study_id