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CompletedNCT03965585Updated Apr 12, 2023

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

An observational study in Infertility, Female, Endometrial Hyperplasia and PCOS, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by University of Campania Luigi Vanvitelli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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".

02

Conditions studied

  • Infertility, Female
  • Endometrial Hyperplasia
  • PCOS
03

In context

Infertility, Female

553 studies on the registry are indexed under Infertility, Female; 136 are open to participants now.

This study's enrollment of 100 is below the median of 161 across 163 observational studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 174 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Southern Italian women eager for children who are set for infertility work-up at a tertiary university hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women undergoing office hysteroscopy prior to IVF techniques

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary Infertility

    Women with a diagnosed primary infertility undergoing hysteroscopy before IVF.

    Procedure: in-office hysteroscopy

  • Secondary Infertility

    Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF.

    Procedure: in-office hysteroscopy

  • Recurrent miscarriages

    Women with recurrent miscarriages undergoing hysteroscopy before IVF.

    Procedure: in-office hysteroscopy

Interventions

  • Procedurein-office hysteroscopy

    in-office hysteroscopy with miniaturized instruments

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What researchers measure

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)

    assess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM).

    Time frame: 12 months

07

Study locations

1 site
  • Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
    Naples, 80138, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03965585
Responsible party
Prof. Pasquale De Franciscis (Associate Professor, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
May 29, 2019
Start date
Jan 2, 2019
Primary completion
Apr 21, 2019
Completion
Apr 30, 2019
Last update
Apr 12, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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