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Histomorphometry Analysis in Fertile and Infertile Patients

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.
ClinicalTrials.gov Identifier: NCT01623063
Recruitment Status : Unknown
Verified June 2012 by Dani Ejzenberg, MD, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Dani Ejzenberg, MD, University of Sao Paulo

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

Condition or disease Intervention/treatment
Infertility Procedure: Hysteroscopy

Detailed Description:
morphometric and pathologyc analysis of the endometrium in fertile and infertile patients

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Histomorphometry Analysis in Fertile and Infertile Patients
Study Start Date : January 2012
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. epitelial surface [ Time Frame: 1 month ]
    to detect differences in the endometrium of fertile and infertile patients



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

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

Responsible Party: Dani Ejzenberg, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01623063     History of Changes
Other Study ID Numbers: EIFMUSP
First Posted: June 19, 2012    Key Record Dates
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