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

Completed

• Conditions: PCOS; Infertility, Female; Endometrial Hyperplasia
• Interventions: Procedure: in-office hysteroscopy

• Registration Number: NCT03965585
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

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 Timeline

• Study Start: 2019-01-02
• Primary Completion: 2019-04-21
• Study Completion: 2019-04-30
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-26
• Study First Posted: 2019-05-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women undergoing office hysteroscopy prior to IVF techniques

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Infertility	in-office hysteroscopy	Women with a diagnosed primary infertility undergoing hysteroscopy before IVF.
Secondary Infertility	in-office hysteroscopy	Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF.
Recurrent miscarriages	in-office hysteroscopy	Women with recurrent miscarriages undergoing hysteroscopy before IVF.

Primary Outcome Measures

Name	Time	Method
Prevalence of endometrial hyperplasia	12 months
Hormonal levels	12 months

Secondary Outcome Measures

Name	Time	Method
Operator's learning curve with cumulative summation test (questionnaire)	12 months	assess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM).

Trial Locations

Locations (1)

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy