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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01780649
First received: January 23, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Infertility
Procedure: IMSI
Procedure: ICSI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of Male Infertility

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Number of Delivery [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of fetal heart beat/ number of transferred embryos


Enrollment: 255
Study Start Date: October 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Intracytoplasmic sperm injection (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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780649

Locations
France
Bagnolet Hospital
Bagnolet, France, 93170
Laboratoire CLEMENT
Le Blanc-Mesnil, France, 93150
Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre
Lille, France, 59037
Hôpital Bichat
Paris, France, 75018
Institut Mutualiste Montsouris
Paris, France, 75014
Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche
Reims, France, 51 100
Laboratoire de Biologie de la Reproduction CECOS
Rouen, France, 76031
Cmco-Sihcus
Schiltigheim, France, 67303
CH des 4 villes
Sevres, France, 92310
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Study Chair: Jean PARINAUD, MD, PhD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01780649     History of Changes
Other Study ID Numbers: 08 117 01, Ministry of Health, PHRC N
Study First Received: January 23, 2013
Last Updated: January 31, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
IMSI
ICSI
ART Assisted reproductive technology
Spermatozoa
male infertility
vacuoles

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 23, 2014