Evaluation of IMSI to Treat Male Infertility

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: IMSI
* Procedure: ICSI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMSI<br>Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) | Procedure: IMSI<br>* 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<br>|
| Active Comparator: ICSI<br>Intracytoplasmic sperm injection (ICSI) | Procedure: ICSI<br>* ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification<br>* Other names: Intracytoplasmic sperm injection (ICSI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Delivery |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Number of fetal heart beat/ number of transferred embryos | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMSI, ICSI, ART Assisted reproductive technology, Spermatozoa, male infertility, vacuoles