NCT03965585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

May 21, 2019

Last Update Submit

April 11, 2023

Conditions

Infertility, FemaleEndometrial HyperplasiaPCOS

Outcome Measures

Primary Outcomes (2)

  • Prevalence of endometrial hyperplasia

    12 months

  • Hormonal levels

    12 months

Secondary Outcomes (1)

  • Operator's learning curve with cumulative summation test (questionnaire)

    12 months

Study Arms (3)

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

in-office hysteroscopyPROCEDURE

in-office hysteroscopy with miniaturized instruments

Primary InfertilityRecurrent miscarriagesSecondary Infertility

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Women undergoing office hysteroscopy prior to IVF techniques

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Infertility, FemaleEndometrial Hyperplasia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityUterine Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 29, 2019

Study Start

January 2, 2019

Primary Completion

April 21, 2019

Study Completion

April 30, 2019

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)