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.
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.
- First posted16 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Alonso, IVI Madrid
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN IMSI AND ICSI TECHNIQUES WITH DONATED EGGS
- ClinicalTrials.gov ID
- NCT01316705
- Acronym / sponsor ID
- MAD-MA-11-2009-02
- Conditions
- Sperm Head
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- - Egg donation cycles
Key inclusion criteria (2 listed)
- teratozzospermia in the sperm sample
- more than 9 oocytes (MII)
Key exclusion criteria (4 listed)
- no egg donation cycles
- less than 10 MII
- vitrified oocytes
- no teratozoospermia males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.