Male InfertilityNCT02107521
IMSI in Couples With Previous Implantation Failures
A study testing Intracytoplasmic morphologically selected sperm injection and Intracytoplasmic sperm injection in people with Male Infertility and Female Infertility, run by Sapientiae Institute at 1 site in Brazil.
Trial summary
There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI. Read more about this study
- Who is it for?
- Ages Up to 38 years, women only
- Conditions the study is for
- Male Infertility, Female Infertility
- What is being tested?
- Intracytoplasmic morphologically selected sperm injection and Intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Oct 2014
- 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 Up to 38 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with ICSI indication, who have previously underwent >= 1 ICSI attempt in which at least 2 blastocysts were transferred, with no implantation.
- Regular menstrual cycles every 25-35 days.
- Body Mass Index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2)
- Presence of both ovaries.
- No pelvic and / or clinically significant uterine anomalies.
- Normal cervical cytology.
- Serum follicle stimulating hormone (FSH) within normal limits.
Who cannot join
- Clinically significant systemic disease.
- Infection by the human immunodeficiency virus (HIV).
- Infection by the by the hepatitis C virus
- Positive test for surface antigens of hepatitis B.
- Endometriosis stages III - IV (classification of the American Society for Reproductive Medicine).
- Hydrosalpinx, unilateral or bilateral.
Show all 9Show fewer
- Abnormal gynecological bleeding, undiagnosed.
- Allergy or hypersensitivity to human gonadotropin preparations or any other related to the study medication.
- -Simultaneous participation in another clinical trial. -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fertility - Centro de Fertilização Assistida
São Paulo, São Paulo, 04503-040
About this study
Official title: The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection
There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI.
- Conditions
- Male Infertility, Female Infertility
- Being tested
- Intracytoplasmic morphologically selected sperm injection, Intracytoplasmic sperm injection
- Keywords
- sperm morphology, ICSI, IMSI, implantation, pregnancy
- Medical subject headings
- Infertility, Male, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracytoplasmic morphologically selected sperm injectionOther
Sperm selection for injection will be performed at 6600x magnification
Intracytoplasmic sperm injectionOther
sperm selection for injection will be performed under 400x magnification
| Study group | Role | What they receive |
|---|---|---|
| ICSI group | Active comparator | In this group, sperm selected for injection will be morphologically evaluated under 400x magnification Receives: Other: Intracytoplasmic sperm injection |
| IMSI group | Experimental | In this group, sperm selected for injection will be morphologically evaluated under 6600x magnification Receives: Other: Intracytoplasmic morphologically selected sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation
The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation
Measured: 4-5 weeks' gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
Why it stopped: broken equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapientiae Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edson Borges, PhD, Principal investigator, Sapientiae Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107521
- Sponsor's protocol ID
- Sapi IMSI IF
- Status last verified
- Aug 2014
- First submitted
- 3 Apr 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT02107521
- Acronym / sponsor ID
- Sapi IMSI IF
- Conditions
- Male Infertility, Female Infertility
- Keywords
- sperm morphology, ICSI, IMSI, implantation, pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: broken equipment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sapientiae InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- First posted
- 8 Apr 2014 (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.
There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI group | Active comparator | Other: Intracytoplasmic sperm injectionIn this group, sperm selected for injection will be morphologically evaluated under 400x magnification |
| IMSI group | Experimental | Other: Intracytoplasmic morphologically selected sperm injectionIn this group, sperm selected for injection will be morphologically evaluated under 6600x magnification |
Who may qualify
- Ages
- Up to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients with ICSI indication, who have previously underwent >= 1 ICSI attempt in which at least 2 blastocysts were transferred, with no implantation.
- Regular menstrual cycles every 25-35 days.
- Body Mass Index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2)
- Presence of both ovaries.
- No pelvic and / or clinically significant uterine anomalies.
Key exclusion criteria (9 listed)
- Clinically significant systemic disease.
- Infection by the human immunodeficiency virus (HIV).
- Infection by the by the hepatitis C virus
- Positive test for surface antigens of hepatitis B.
- Endometriosis stages III - IV (classification of the American Society for Reproductive Medicine).
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 |
|---|---|---|
| Intracytoplasmic morphologically selected sperm injectionSperm selection for injection will be performed at 6600x magnification | Other | IMSI group |
| Intracytoplasmic sperm injectionsperm selection for injection will be performed under 400x magnification | Other | ICSI group |
Primary outcome
Implantation
Time frame: 4-5 weeks' gestation
The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation
Results and safety
The study was stopped early (reason given: broken equipment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
Edson Borges, PhD principal investigator
Sapientiae Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracytoplasmic morphologically selected sperm injection and Intracytoplasmic sperm injection in people with Male Infertility and Female Infertility, run by Sapientiae Institute at 1 site in Brazil.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 was stopped early (reason given: broken equipment). Results are not available in the source record.
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?
Implantation (time frame: 4-5 weeks' gestation). 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 18 Nov 2014.