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

Study Overview
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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.

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

Conditions
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Infertility, Female, Endometrial Hyperplasia, PCOS

Intervention / Treatment
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* Procedure: in-office hysteroscopy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Infertility<br>Women with a diagnosed primary infertility undergoing hysteroscopy before IVF. | Procedure: in-office hysteroscopy<br>* in-office hysteroscopy with miniaturized instruments<br>|
| Secondary Infertility<br>Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF. | Procedure: in-office hysteroscopy<br>* in-office hysteroscopy with miniaturized instruments<br>|
| Recurrent miscarriages<br>Women with recurrent miscarriages undergoing hysteroscopy before IVF. | Procedure: in-office hysteroscopy<br>* in-office hysteroscopy with miniaturized instruments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of endometrial hyperplasia |  | 12 months | 
| Hormonal levels |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |