NCT01780649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

January 23, 2013

Last Update Submit

January 31, 2013

Conditions

Infertility

Keywords

IMSIICSIART Assisted reproductive technologySpermatozoamale infertilityvacuoles

Outcome Measures

Primary Outcomes (1)

  • Number of Delivery

    9 months

Secondary Outcomes (1)

  • Implantation rate

    3 months

Study Arms (2)

IMSI

EXPERIMENTAL

Intracytoplasmic Morphologically Selected Sperm Injection (IMSI)

Procedure: IMSI

ICSI

ACTIVE COMPARATOR

Intracytoplasmic sperm injection (ICSI)

Procedure: ICSI

Interventions

IMSIPROCEDURE

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

IMSI
ICSIPROCEDURE

ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification

Also known as: Intracytoplasmic sperm injection (ICSI)
ICSI

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Female age \> 38
  • Female follicle stimulating hormone (FSH) level \> 9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Bagnolet Hospital

Bagnolet, 93170, France

Location

Laboratoire CLEMENT

Le Blanc-Mesnil, 93150, France

Location

Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre

Lille, 59037, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche

Reims, 51 100, France

Location

Laboratoire de Biologie de la Reproduction CECOS

Rouen, 76031, France

Location

Cmco-Sihcus

Schiltigheim, 67303, France

Location

CH des 4 villes

Sèvres, 92310, France

Location

MeSH Terms

Conditions

InfertilityInfertility, Male

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Jean PARINAUD, MD, PhD

    University Hospital, Toulouse

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 31, 2013

Study Start

October 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

FR(9)