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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IMSI
ICSI
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IMSI, ICSI, ART Assisted reproductive technology, Spermatozoa, male infertility, vacuoles

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Bagnolet Hospital
  • Laboratoire CLEMENT
  • Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre
  • Institut Mutualiste Montsouris
  • Hôpital Bichat
  • Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche
  • Laboratoire de Biologie de la Reproduction CECOS
  • Cmco-Sihcus
  • CH des 4 villes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMSI

ICSI

Arm Description

Intracytoplasmic Morphologically Selected Sperm Injection (IMSI)

Intracytoplasmic sperm injection (ICSI)

Outcomes

Primary Outcome Measures

Number of Delivery

Secondary Outcome Measures

Implantation rate
Number of fetal heart beat/ number of transferred embryos

Full Information

First Posted
January 23, 2013
Last Updated
January 31, 2013
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01780649
Brief Title
Evaluation of IMSI to Treat Male Infertility
Acronym
PHRC-IMSI
Official Title
Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of Male Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IMSI, ICSI, ART Assisted reproductive technology, Spermatozoa, male infertility, vacuoles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMSI
Arm Type
Experimental
Arm Description
Intracytoplasmic Morphologically Selected Sperm Injection (IMSI)
Arm Title
ICSI
Arm Type
Active Comparator
Arm Description
Intracytoplasmic sperm injection (ICSI)
Intervention Type
Procedure
Intervention Name(s)
IMSI
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
ICSI
Other Intervention Name(s)
Intracytoplasmic sperm injection (ICSI)
Intervention Description
ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification
Primary Outcome Measure Information:
Title
Number of Delivery
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Implantation rate
Description
Number of fetal heart beat/ number of transferred embryos
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean PARINAUD, MD, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Study Chair
Facility Information:
Facility Name
Bagnolet Hospital
City
Bagnolet
ZIP/Postal Code
93170
Country
France
Facility Name
Laboratoire CLEMENT
City
Le Blanc-Mesnil
ZIP/Postal Code
93150
Country
France
Facility Name
Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche
City
Reims
ZIP/Postal Code
51 100
Country
France
Facility Name
Laboratoire de Biologie de la Reproduction CECOS
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Cmco-Sihcus
City
Schiltigheim
ZIP/Postal Code
67303
Country
France
Facility Name
CH des 4 villes
City
Sevres
ZIP/Postal Code
92310
Country
France

12. IPD Sharing Statement

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Evaluation of IMSI to Treat Male Infertility

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