Evaluation of IMSI to Treat Male Infertility

Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of Male Infertility

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01780649

Acronym

PHRC-IMSI

Enrollment

255

Registered

2013-01-31

Start date

2008-10-31

Completion date

2013-01-31

Last updated

2013-02-01

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

Conditions

Infertility

Keywords

IMSI, ICSI, ART Assisted reproductive technology, Spermatozoa, male infertility, vacuoles

Brief summary

Intracytoplasmic Morphologically Selected Sperm (IMSI) is a modification of IntraCytoplasmic Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x magnification instead of 400x commonly used in ICSI. The purpose of this study is to evaluate the efficiency and the indications of IMSI through a multicentric randomised trial.

Detailed description

Intracytoplasmic sperm injection (ICSI) is largely used to treat male infertility. Usually, choice of the spermatozoon to be injected is done at a 400x magnification. Recently, a new microscopic technic (Intracytoplasmic Morphologically Selected Sperm Injection-IMSI) allows to make this choice at a 6000x magnification, which permits to identify sperm abnormalities such as nuclear vacuoles not seen in conventional ICSI. This selection may improve ICSI outcome. However only few data from randomised trials, have been published and the indications of IMSI remain to be identified. The present study aims to evaluate the efficiency and the indications of IMSI through a multicentric randomised trial. The patients enrolled in the study must present a male infertility and will have complete sperm examination, including morphology, DNA fragmentation and nuclear immaturity. The main endpoint will be the percentage of delivery.

Interventions

PROCEDUREIMSI

Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) is a modification of IntraCytoplasmic Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x magnification instead of 400x commonly used in ICSI

PROCEDUREICSI

ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 38 Years

Healthy volunteers

Inclusion criteria

* male infertility with less than 1 million of motile spermatozoa recovered after gradient preparation and at least 3 millions of sperm cells in the ejaculate * First Assisted reproductive technology (ART) attempt

Exclusion criteria

* Female age \> 38 * Female follicle stimulating hormone (FSH) level \> 9

Design outcomes

Primary

Measure	Time frame
Number of Delivery	9 months

Secondary

Measure	Time frame	Description
Implantation rate	3 months	Number of fetal heart beat/ number of transferred embryos

Countries

France

Outcome results

None listed

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