Histomorphometry Analysis in Fertile and Infertile Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014