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

April 11, 2023 updated by: Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli"

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • Women undergoing office hysteroscopy prior to IVF techniques

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of endometrial hyperplasia
Time Frame: 12 months
12 months
Hormonal levels
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Actual)

April 21, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 26, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N.593

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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