Evaluation of IMSI to Treat Male Infertility

Infertility Clinical Trial

— PHRC-IMSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780649
• Other study ID #: 08 117 01
• Secondary ID: Ministry of Heal
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: January 31, 2013
• Start date: October 2008
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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

Locations

Country	Name	City	State
France	Bagnolet Hospital	Bagnolet
France	Laboratoire CLEMENT	Le Blanc-Mesnil
France	Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre	Lille
France	Hôpital Bichat	Paris
France	Institut Mutualiste Montsouris	Paris
France	Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche	Reims
France	Laboratoire de Biologie de la Reproduction CECOS	Rouen
France	Cmco-Sihcus	Schiltigheim
France	CH des 4 villes	Sevres

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Delivery		9 months	No
Secondary	Implantation rate	Number of fetal heart beat/ number of transferred embryos	3 months	No