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Completed

NCT Number: NCT03965585

Office Hysteroscopy in 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.

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Key information

Conditions

Infertility, Female Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility PCOS Urogenital Diseases Uterine Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Naples, 80138, Italy

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women undergoing office hysteroscopy prior to IVF techniques

Exclusion criteria

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

Treatment and study plan

in-office hysteroscopy

Procedure

in-office hysteroscopy with miniaturized instruments

Primary outcomes

  1. Prevalence of endometrial hyperplasia

    Time frame: 12 months

  2. Hormonal levels

    Time frame: 12 months

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2019
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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