Back to resultsHistomorphometry Analysis in Fertile and Infertile Patients
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hysteroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring endometrium, infertility, uterus, histeroscopy
Eligibility Criteria
Inclusion Criteria:
- 18 to 41 years old
- regular menses
- infertility over 12 months
Exclusion Criteria:
- previous uterine surgery
- use of contraceptive pills or injections less than 3 months from the inclusion in the study
Sites / Locations
- Hospital das ClinicasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Infertile
Fertile
Arm Description
patients from our human reproduction center
patients with comproved fertility
Outcomes
Primary Outcome Measures
glandular volume
verify the glandular volume in fertile and infertil patients during the implantation window
Secondary Outcome Measures
epitelial surface
to detect differences in the endometrium of fertile and infertile patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01623063
Brief Title
Histomorphometry Analysis in Fertile and Infertile Patients
Official Title
Histomorphometry Analysis in Fertile and Infertile Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
endometrium, infertility, uterus, histeroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infertile
Arm Type
Experimental
Arm Description
patients from our human reproduction center
Arm Title
Fertile
Arm Type
Active Comparator
Arm Description
patients with comproved fertility
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Other Intervention Name(s)
Bettocchi system- Karl Storz, pipelle- cornier
Intervention Description
hysteroscopy with guided biopsies
Primary Outcome Measure Information:
Title
glandular volume
Description
verify the glandular volume in fertile and infertil patients during the implantation window
Time Frame
1 month
Secondary Outcome Measure Information:
Title
epitelial surface
Description
to detect differences in the endometrium of fertile and infertile patients
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 41 years old
regular menses
infertility over 12 months
Exclusion Criteria:
previous uterine surgery
use of contraceptive pills or injections less than 3 months from the inclusion in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dani Ejzenberg, MD
Phone
55 11 92828550
Email
daejz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dani Ejzenberg
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dani Ejzenberg, MD
Phone
55 11 92828550
Email
daejz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dani Ejzenberg, MD
12. IPD Sharing Statement
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Histomorphometry Analysis in Fertile and Infertile Patients
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