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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: IMSI; Procedure: ICSI

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 Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bagnolet, France, 93170
    • Bagnolet Hospital
  • Le Blanc-Mesnil, France, 93150
    • Laboratoire CLEMENT
  • Lille, France, 59037
    • Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75018
    • Hopital Bichat
  • Reims, France, 51 100
    • Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche
  • Rouen, France, 76031
    • Laboratoire de Biologie de la Reproduction CECOS
  • Schiltigheim, France, 67303
    • Cmco-Sihcus
  • Sevres, France, 92310
    • CH des 4 villes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Chair: Jean PARINAUD, MD, PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: male infertility; ICSI; IMSI; ART Assisted reproductive technology; Spermatozoa; vacuoles
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: 08 117 01; Ministry of Health, PHRC N (Other Grant/Funding Number: Ministry of Health)