InfertilityNCT01623063
Histomorphometry Analysis in Fertile and Infertile Patients
A study testing Hysteroscopy in people with Infertility, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
To detect similarities and differences in the endometrium of fertile and infertile patients Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to 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 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 41 years old
- regular menses
- infertility over 12 months
Who cannot join
- previous uterine surgery
- use of contraceptive pills or injections less than 3 months from the inclusion in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas
São Paulo, São Paulo, 05403000
Dani Ejzenberg, MD, 55 11 92828550, daejz@hotmail.com
Dani Ejzenberg, MD
About this study
To detect similarities and differences in the endometrium of fertile and infertile patients
Read the detailed description
morphometric and pathologyc analysis of the endometrium in fertile and infertile patients
- Conditions
- Infertility
- Being tested
- Hysteroscopy
- Keywords
- endometrium, infertility, uterus, histeroscopy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
Also called Bettocchi system- Karl Storz, pipelle- cornier
hysteroscopy with guided biopsies
| Study group | Role | What they receive |
|---|---|---|
| Infertile | Experimental | patients from our human reproduction center Receives: Procedure: Hysteroscopy |
| Fertile | Active comparator | patients with comproved fertility Receives: Procedure: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
glandular volume
verify the glandular volume in fertile and infertil patients during the implantation window
Measured: 1 month
Secondary outcomes (1)
epitelial surface
to detect differences in the endometrium of fertile and infertile patients
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
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 of Sao PauloThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dani Ejzenberg, MD, University of Sao Paulo
- Investigators
- Dani Ejzenberg, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623063
- Sponsor's protocol ID
- EIFMUSP
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histomorphometry Analysis in Fertile and Infertile Patients
- ClinicalTrials.gov ID
- NCT01623063
- Acronym / sponsor ID
- EIFMUSP
- Conditions
- Infertility
- Keywords
- endometrium, infertility, uterus, histeroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 19 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.
To detect similarities and differences in the endometrium of fertile and infertile patients
Detailed description
morphometric and pathologyc analysis of the endometrium in fertile and infertile patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile | Experimental | Procedure: Hysteroscopypatients from our human reproduction center |
| Fertile | Active comparator | Procedure: Hysteroscopypatients with comproved fertility |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 41 years old
- regular menses
- infertility over 12 months
Key exclusion criteria (2 listed)
- previous uterine surgery
- use of contraceptive pills or injections less than 3 months from the inclusion in the study
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 |
|---|---|---|
| HysteroscopyAlso: Bettocchi system- Karl Storz, pipelle- cornierhysteroscopy with guided biopsies | Procedure or surgery | Fertile, Infertile |
Primary outcome
glandular volume
Time frame: 1 month
verify the glandular volume in fertile and infertil patients during the implantation window
1 secondary outcome
epitelial surface
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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.
Dani Ejzenberg principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy in people with Infertility, run by University of Sao Paulo 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 3 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: status not confirmed, as of the sponsor's last update on 19 Jun 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dani Ejzenberg, MD (55 11 92828550, daejz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glandular volume (time frame: 1 month). 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 19 Jun 2012.