InfertilityPHRC-IMSINCT01780649
Evaluation of IMSI to Treat Male Infertility
A study testing IMSI and ICSI in people with Infertility, run by University Hospital, Toulouse at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Infertility
- What is being tested?
- IMSI and ICSI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 9 sitesFrance
- Study dates
- Oct 2008to Jan 2013
- Phase
- Interventional
- 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 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Female age > 38
- Female follicle stimulating hormone (FSH) level > 9
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Bagnolet Hospital
Bagnolet, 93170
Laboratoire CLEMENT
Le Blanc-Mesnil, 93150
Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre
Lille, 59037
Institut Mutualiste Montsouris
Paris, 75014
Hôpital Bichat
Paris, 75018
Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche
Reims, 51 100
Laboratoire de Biologie de la Reproduction CECOS
Rouen, 76031
Cmco-Sihcus
Schiltigheim, 67303
CH des 4 villes
Sèvres, 92310
About this study
Official title: Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of 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.
Read the detailed 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.
- Conditions
- Infertility
- Being tested
- IMSI, ICSI
- Keywords
- IMSI, ICSI, ART Assisted reproductive technology, Spermatozoa, male infertility, vacuoles
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMSIProcedure or surgery
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
ICSIProcedure or surgery
Also called Intracytoplasmic sperm injection (ICSI)
ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification
| Study group | Role | What they receive |
|---|---|---|
| IMSI | Experimental | Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Receives: Procedure: IMSI |
| ICSI | Active comparator | Intracytoplasmic sperm injection (ICSI) Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Delivery
Measured: 9 months
Secondary outcomes (1)
Implantation rate
Number of fetal heart beat/ number of transferred embryos
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startOct 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean PARINAUD, MD, PhD, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780649
- Sponsor's protocol ID
- 08 117 01
- Other IDs
- Ministry of Health, PHRC N
- Acronym
- PHRC-IMSI
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of Male Infertility
- ClinicalTrials.gov ID
- NCT01780649
- Acronym / sponsor ID
- PHRC-IMSI / 08 117 01
- Conditions
- Infertility
- Keywords
- IMSI, ICSI, ART Assisted reproductive technology, Spermatozoa, male infertility, vacuoles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Jan 2013 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMSI | Experimental | Procedure: IMSIIntracytoplasmic Morphologically Selected Sperm Injection (IMSI) |
| ICSI | Active comparator | Procedure: ICSIIntracytoplasmic sperm injection (ICSI) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Female age > 38
- Female follicle stimulating hormone (FSH) level > 9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMSIIntracytoplasmic 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 | Procedure or surgery | IMSI |
| ICSIAlso: Intracytoplasmic sperm injection (ICSI)ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification | Procedure or surgery | ICSI |
Primary outcome
Number of Delivery
Time frame: 9 months
1 secondary outcome
Implantation rate
Time frame: 3 months
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 1 Feb 2013.
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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.
Jean PARINAUD, MD, PhD study chair
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMSI and ICSI in people with Infertility, run by University Hospital, Toulouse at 9 sites in France.
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 2 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 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Number of Delivery (time frame: 9 months). It is what the study was designed to measure, not a finding.
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 1 Feb 2013.