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Histomorphometry Analysis in Fertile and Infertile Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Dani Ejzenberg, MD, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623063
First Posted: June 19, 2012
Last Update Posted: June 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dani Ejzenberg, MD, University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Histomorphometry Analysis in Fertile and Infertile Patients

Resource links provided by NLM:


Further study details as provided by Dani Ejzenberg, MD, University of Sao Paulo:

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


Secondary Outcome Measures:
  • epitelial surface [ Time Frame: 1 month ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dani Ejzenberg, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01623063     History of Changes
Other Study ID Numbers: EIFMUSP
First Submitted: June 15, 2012
First Posted: June 19, 2012
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Dani Ejzenberg, MD, University of Sao Paulo:
endometrium
infertility
uterus
histeroscopy

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


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