Clinical trial NCT01780649: Evaluation of IMSI to Treat Male Infertility
Official title: Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of Male Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IMSI
ICSI
ART Assisted reproductive technology
Spermatozoa
male infertility
vacuoles
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Delivery
timeFrame: 9 months
Secondary outcomes:
measure: Implantation rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Bagnolet
country: France
facility: Bagnolet Hospital
city: Le Blanc-Mesnil
country: France
facility: Laboratoire CLEMENT
city: Lille
country: France
facility: Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Bichat
city: Reims
country: France
facility: Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche
city: Rouen
country: France
facility: Laboratoire de Biologie de la Reproduction CECOS
city: Schiltigheim
country: France
facility: Cmco-Sihcus
city: Sevres
country: France
facility: CH des 4 villes
Study officials:
affiliation: University Hospital, Toulouse
name: Jean PARINAUD, MD, PhD
role: STUDY_CHAIR
References: