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Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women

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: NCT03965585
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli"

Brief Summary:
To assess the prevalence of endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN) and endometrial carcinoma between obese and not obese women undergoing IVF techniques for primary or secondary infertility.

Condition or disease Intervention/treatment
Infertility, Female Endometrial Hyperplasia PCOS Procedure: in-office hysteroscopy

Detailed Description:

Endometrial cancer and pre-neoplastic diseases represent the most incident gynecologic malignant pathologies found in women.1 Although diagnosed in postmenopausal patients, it can be also found in younger patients, especially when associated with some risk factors. Those include weight gain and lifestyle habits, such as consumption of fatty foods that increase estrogen levels. The positive association be- tween infertility and EC is well established. Infertile women with irregular menstrual periods, oligomenorrhea, or chronic anovulation have a risk of developing

A prospective cohort study conducted at "Fertility Center, OB/GYN Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy".

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Office Hysteroscopy in the Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : April 21, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
Primary Infertility
Women with a diagnosed primary infertility undergoing hysteroscopy before IVF.
Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments

Secondary Infertility
Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF.
Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments

Recurrent miscarriages
Women with recurrent miscarriages undergoing hysteroscopy before IVF.
Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments




Primary Outcome Measures :
  1. Prevalence of endometrial hyperplasia [ Time Frame: 12 months ]
  2. Hormonal levels [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Operator's learning curve with cumulative summation test (questionnaire) [ Time Frame: 12 months ]
    assess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Southern Italian women eager for children who are set for infertility work-up at a tertiary university hospital
Criteria

Inclusion Criteria:

  • Women undergoing office hysteroscopy prior to IVF techniques

Exclusion Criteria:

  • Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)

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): NCT03965585


Locations
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Italy
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
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Responsible Party: Prof. Pasquale De Franciscis, Associate Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03965585    
Other Study ID Numbers: N.593
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Uterine Diseases