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OpenTrials
Completed

NCT Number: NCT01780649

Evaluation of IMSI to Treat 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.

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Key information

Conditions

Infertility Genital Diseases Genital Diseases, Male Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bagnolet Hospital, Bagnolet, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMSI

Procedure

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

ICSI

Procedure

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

Other names: Intracytoplasmic sperm injection (ICSI)

Primary outcomes

  1. Number of Delivery

    Time frame: 9 months

Secondary outcomes

  1. Implantation rate

    Time frame: 3 months

    Number of fetal heart beat/ number of transferred embryos

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PHRC-IMSI

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2013
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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