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Histomorphometry Analysis in Fertile and Infertile Patients

This study is currently recruiting participants.
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Dani Ejzenberg, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01623063
First received: June 15, 2012
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

To detect similarities and differences in the endometrium of fertile and infertile patients


Condition Intervention
Infertility
 Procedure: Hysteroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Histomorphometry Analysis in Fertile and Infertile Patients

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • glandular volume [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    verify the glandular volume in fertile and infertil patients during the implantation window


Secondary Outcome Measures:
  • epitelial surface [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    to detect differences in the endometrium of fertile and infertile patients


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infertile
patients from our human reproduction center
 Procedure: Hysteroscopy
hysteroscopy with guided biopsies
Other Names:
  • Bettocchi system- Karl Storz
  • pipelle- cornier
Active Comparator: Fertile
patients with comproved fertility
 Procedure: Hysteroscopy
hysteroscopy with guided biopsies
Other Names:
  • Bettocchi system- Karl Storz
  • pipelle- cornier

Detailed Description:

morphometric and pathologyc analysis of the endometrium in fertile and infertile patients

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623063

Contacts
Contact: Dani Ejzenberg, MD 55 11 92828550 daejz@hotmail.com

Locations
Brazil
Hospital das Clinicas Recruiting
Sao Paulo, Brazil, 05403000
Contact: Dani Ejzenberg, MD     55 11 92828550     daejz@hotmail.com    
Principal Investigator: Dani Ejzenberg, MD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Dani Ejzenberg University of Sao Paulo
  More Information

No publications provided

Responsible Party: Dani Ejzenberg, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01623063     History of Changes
Other Study ID Numbers: EIFMUSP
Study First Received: June 15, 2012
Last Updated: June 18, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
endometrium
infertility
uterus
histeroscopy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013