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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03965585
Enrollment
100
Registered
2019-05-29
Start date
2019-01-02
Completion date
2019-04-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Hyperplasia, Infertility, Female, PCOS

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.

Interventions

in-office hysteroscopy with miniaturized instruments

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Women undergoing office hysteroscopy prior to IVF techniques

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Prevalence of endometrial hyperplasia12 months
Hormonal levels12 months

Secondary

MeasureTime frameDescription
Operator's learning curve with cumulative summation test (questionnaire)12 monthsassess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026