Comparison Between Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) And Intra Cytoplasmic Sperm Injection (ICSI) Techniques With Eggs Donated

April 3, 2018 updated by: Manuela Alonso, IVI Madrid

COMPARISON BETWEEN IMSI AND ICSI TECHNIQUES WITH DONATED EGGS

This study aims to determine if early embryonic development, in D2 and D3 and the blastocyst, is compromised by the fine morphology of sperm nucleus. This will draw the IMSI, in which sperm will be chosen using the classification MSOME and ICSI in which sperm morphology is elected with less magnification. Both techniques are performed in oocytes of donor , being the coohorte used for both techniques picked at random. All courses will begin as a crop sequence, using the criteria of the IVF laboratory. Transfers will be made in blastocyst stage (D5 or D6), except in cases where the number of fertilized is less than 6 or fewer than 6 embryos of acceptable quality in D3, which would transfer the same D3 . With donor oocytes, the quality of these need not be compromised and to perform the same technique in all oocytes results in pure transfers with both techniques. It allows us to compare results in term of pregnancy, implantation and early abortion rate, as well as embryo quality.

Study Overview

Status

Completed

Conditions

Detailed Description

ICSI is the most frequent insemination method used at all IVI clinics. This technique allows the observation of both, oocytes and spermatozoa, at a maximum magnification of 400X. At this magnification we are only able to assess gross morphological characteristics such as: double heads, double tails, globozoospermia, megalozoospermia.

Nowadays, many groups are using a new method to select spermatozoa known as MSOME (high magnification motile sperm organelle morphology examination) (Bartoov B, et al.,2002). This method allows us to perform a fine assessment of the sperm nucleus and to select at a very high magnification and in real time. The magnification used is between 600 and 13500x.

Later the group of Bartoov introduced the IMSI (intracytoplasmic morphologically selected sperm injection) (Bartoov B., et al., 2003), allowing the single microinjection of selected motile spermatozoa with strictly defined morphologically normal nuclei into the cytoplasm of retrieved oocytes. This prospective controlled study, performed in couples with male infertility and at least two previous failed ICSI attempts, showed that IMSI resulted in a significantly higher pregnancy and implantation rate as compared with conventional ICSI. From their results they assume that in the IMSI, the survival of the embryo in the uterus is associated with the fine morphological state of the sperm nucleus.

Following these data have been some groups, such as Antinori M. et al., 2007, or Vanderzwalmen P et al., 2007 and 2008, showing spectacular results in pregnancy and implantation rate with this new technique, in couples who had several unsuccessful cycles of assisted reproduction. One objection of this work is that all comparisons have been made by relating the results of the IMSI with retrospective results of previous cycles of ICSI.

This study aims to determine if early embryonic development, in D2 and D3 and the blastocyst, is compromised by the fine morphology of sperm nucleus. This will draw the IMSI, in which sperm will be chosen using the classification MSOME and ICSI in which sperm morphology is elected with less magnification. Both techniques are performed in oocytes of donor , being the coohorte used for both techniques picked at random. All courses will begin as a crop sequence, using the criteria of the IVF laboratory. Transfers will be made in blastocyst stage (D5 or D6), except in cases where the number of fertilized is less than 6 or fewer than 6 embryos of acceptable quality in D3, which would transfer the same D3 . With donor oocytes, the quality of these need not be compromised and to perform the same technique in all oocytes results in pure transfers with both techniques. It allows us to compare results in term of pregnancy, implantation and early abortion rate, as well as embryo quality.

Study Type

Observational

Enrollment (Actual)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

- Egg donation cycles

Description

Inclusion Criteria:

  • teratozzospermia in the sperm sample
  • more than 9 oocytes (MII)

Exclusion Criteria:

  • no egg donation cycles
  • less than 10 MII
  • vitrified oocytes
  • no teratozoospermia males

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MAD-MA-11-2009-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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