Female InfertilityIMSIAMANCT01620346
Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age
A study testing Intracytoplasmic sperm injection (ICSI) and Intracytoplasmic morphologically selected sperm injection in people with Female Infertility, run by Sapientiae Institute at 1 site in Brazil.
Trial summary
The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI). This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years… Read more about this study
- Who is it for?
- Ages 37 years and older, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Intracytoplasmic sperm injection (ICSI) and Intracytoplasmic morphologically selected sperm injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Aug 2012
- 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 37 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good physical and mental health
- Advanced maternal age (≥ 37 years old)
- Regular menstrual cycles of 25-35 days
- Normal basal FSH and LH levels
- Body mass index less than 30 kg/m2
- Presence of both ovaries
- Intact uterus
- No hormone therapy for at least 60 days preceding the study
Who cannot join
- Polycystic ovaries
- Endometriosis
- Gynaecological/medical disorders
- Positive result in a screening for sexually transmitted diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fertility - Assisted Fertilization Center
São Paulo, São Paulo, 04512001
About this study
Official title: Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study
The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI).
This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.
- Conditions
- Female Infertility
- Being tested
- Intracytoplasmic sperm injection (ICSI), Intracytoplasmic morphologically selected sperm injection
- Keywords
- advanced maternal age, infertility, IMSI, ICSI, implantation
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracytoplasmic sperm injection (ICSI)Procedure or surgery
ICSI is routinely used to treat couples with infertility. Sperm selection in the ICSI group was analysed under a magnification of 400x using an inverted microscope. ICSI was performed in a micro-injection dish prepared with 4 µL droplets of buffered medium (Global® w/HEPES, LifeGlobal, Connecticut, USA) and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
Intracytoplasmic morphologically selected sperm injectionProcedure or surgery
IMSI is an established modified ICSI procedure that used an unstained real-time observation of spermatozoa under high-magnification. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection.
| Study group | Role | What they receive |
|---|---|---|
| ICSI group | Active comparator | This group was provided with conventional intracytoplasmic sperm injection (ICSI). This treatment is routinely used to treat infertility. Sperm selection in the ICSI group is analysed under a magnification of 400x using an inverted microscope. Receives: Procedure: Intracytoplasmic sperm injection (ICSI) |
| Intracytoplasmic morphologically selected sperm injection | Experimental | Intracytoplasmic morphologically selected sperm injection (IMSI) is an established modified ICSI procedure. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection. Receives: Procedure: Intracytoplasmic morphologically selected sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Number of embryos implanted in the uterus divided for the number of embryos transferred.
Measured: 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapientiae Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edson Borges Jr., MD., Ph.D, Principal investigator, Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620346
- Sponsor's protocol ID
- Sapi2012_1
- Acronym
- IMSIAMA
- Status last verified
- Jan 2013
- First submitted
- 13 Jun 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01620346
- Acronym / sponsor ID
- IMSIAMA / Sapi2012_1
- Conditions
- Female Infertility
- Keywords
- advanced maternal age, infertility, IMSI, ICSI, implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sapientiae InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Jun 2012 (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.
The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI).
This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI group | Active comparator | Procedure: Intracytoplasmic sperm injection (ICSI)This group was provided with conventional intracytoplasmic sperm injection (ICSI). This treatment is routinely used to treat infertility. Sperm selection in the ICSI group is analysed under a magnification of 400x using an inverted microscope. |
| Intracytoplasmic morphologically selected sperm injection | Experimental | Procedure: Intracytoplasmic morphologically selected sperm injectionIntracytoplasmic morphologically selected sperm injection (IMSI) is an established modified ICSI procedure. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection. |
Who may qualify
- Ages
- 37 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Good physical and mental health
- Advanced maternal age (≥ 37 years old)
- Regular menstrual cycles of 25-35 days
- Normal basal FSH and LH levels
- Body mass index less than 30 kg/m2
Key exclusion criteria (4 listed)
- Polycystic ovaries
- Endometriosis
- Gynaecological/medical disorders
- Positive result in a screening for sexually transmitted diseases
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 sperm injection (ICSI)ICSI is routinely used to treat couples with infertility. Sperm selection in the ICSI group was analysed under a magnification of 400x using an inverted microscope. ICSI was performed in a micro-injection dish prepared with 4 µL droplets of buffered medium (Global® w/HEPES, LifeGlobal, Connecticut, USA) and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope. | Procedure or surgery | ICSI group |
| Intracytoplasmic morphologically selected sperm injectionIMSI is an established modified ICSI procedure that used an unstained real-time observation of spermatozoa under high-magnification. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection. | Procedure or surgery | Intracytoplasmic morphologically selected sperm injection |
Primary outcome
Implantation rate
Time frame: 6 weeks after embryo transfer
Number of embryos implanted in the uterus divided for the number of embryos transferred.
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 8 Jan 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.
Edson Borges Jr., MD., Ph.D principal investigator
Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction
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 sperm injection (ICSI) and Intracytoplasmic morphologically selected sperm injection in people with 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 8 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 8 Jan 2013. 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 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?
Implantation rate (time frame: 6 weeks after embryo transfer). 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 8 Jan 2013.