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

NCT ID: NCT03965585

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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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".

Conditions

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Infertility, Female Endometrial Hyperplasia PCOS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Infertility

Women with a diagnosed primary infertility undergoing hysteroscopy before IVF.

in-office hysteroscopy

Intervention Type PROCEDURE

in-office hysteroscopy with miniaturized instruments

Secondary Infertility

Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF.

in-office hysteroscopy

Intervention Type PROCEDURE

in-office hysteroscopy with miniaturized instruments

Recurrent miscarriages

Women with recurrent miscarriages undergoing hysteroscopy before IVF.

in-office hysteroscopy

Intervention Type PROCEDURE

in-office hysteroscopy with miniaturized instruments

Interventions

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in-office hysteroscopy

in-office hysteroscopy with miniaturized instruments

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing office hysteroscopy prior to IVF techniques

Exclusion Criteria

* Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Prof. Pasquale De Franciscis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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N.593

Identifier Type: -

Identifier Source: org_study_id

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