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Sperm HeadNCT01316705

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

An observational study of Sperm Head, run by IVI Madrid.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Sperm Head
How many people
25 participants
Where
No sites listed yet
Study dates
Apr 2010to Jul 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: - Egg donation cycles

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Conditions
Sperm Head

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2011 (estimated)
  2. Study startApr 2010
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316705
Sponsor's protocol ID
MAD-MA-11-2009-02
Status last verified
Apr 2018
First submitted
15 Mar 2011
Last updated
4 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sperm Head, run by IVI Madrid.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.

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