Evaluation of IMSI to Treat Male Infertility (PHRC-IMSI)

Toulouse University Hospital

Status: Completed

Conditions: Infertility

Treatments: Procedure: IMSI; Procedure: ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT01780649

Ministry of Health, PHRC N (Other Grant/Funding Number)

08 117 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 255 patients

Sex: All

Ages: 18 to 38 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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255 participants in 2 patient groups

IMSI

Experimental group

Description:

Intracytoplasmic Morphologically Selected Sperm Injection (IMSI)

Treatment:

Procedure: IMSI

ICSI

Active Comparator group

Description:

Intracytoplasmic sperm injection (ICSI)

Treatment:

Procedure: ICSI