Evaluation of IMSI to Treat Male Infertility

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: IMSI; Procedure: ICSI

• Registration Number: NCT01780649
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2008-10
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-31
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMSI	IMSI	Intracytoplasmic Morphologically Selected Sperm Injection (IMSI)
ICSI	ICSI	Intracytoplasmic sperm injection (ICSI)

Primary Outcome Measures

Name	Time	Method
Number of Delivery	9 months

Secondary Outcome Measures

Name	Time	Method
Implantation rate	3 months	Number of fetal heart beat/ number of transferred embryos

Trial Locations

Locations (9)

Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre; 🇫🇷 Lille, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Bagnolet Hospital; 🇫🇷 Bagnolet, France

Laboratoire de Biologie de la Reproduction CECOS; 🇫🇷 Rouen, France

Hôpital Bichat; 🇫🇷 Paris, France

Laboratoire CLEMENT; 🇫🇷 Le Blanc-Mesnil, France

Cmco-Sihcus; 🇫🇷 Schiltigheim, France

Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche; 🇫🇷 Reims, France

CH des 4 villes; 🇫🇷 Sevres, France