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NCT03965585 Clinical Trial

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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03965585
Other study ID # N.593
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date April 30, 2019

Study information
Verified date April 2023
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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".

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 30, 2019
Est. primary completion date April 21, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Women undergoing office hysteroscopy prior to IVF techniques Exclusion Criteria: - Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments

Locations
Country Name City State
Italy Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli" Naples

Sponsors (1)
Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of endometrial hyperplasia 12 months
Primary Hormonal levels 12 months
Secondary Operator's learning curve with cumulative summation test (questionnaire) assess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM). 12 months
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