Infertility, FemaleNCT03965585
Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
An observational study of Infertility, Female and Endometrial Hyperplasia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female, Endometrial Hyperplasia, PCOS
- What is being tested?
- in-office hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2019to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Southern Italian women eager for children who are set for infertility work-up at a tertiary university hospital
Who may be able to join
- Women undergoing office hysteroscopy prior to IVF techniques
Who cannot join
- Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Naples, 80138
About this study
Official title: Office Hysteroscopy in the Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
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".
- Conditions
- Infertility, Female, Endometrial Hyperplasia, PCOS
- Being tested
- in-office hysteroscopy
- Medical subject headings
- Infertility, Female, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-office hysteroscopyProcedure or surgery
in-office hysteroscopy with miniaturized instruments
| Study group | Role | What they receive |
|---|---|---|
| Primary Infertility | Women with a diagnosed primary infertility undergoing hysteroscopy before IVF. Receives: Procedure: in-office hysteroscopy | |
| Secondary Infertility | Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF. Receives: Procedure: in-office hysteroscopy | |
| Recurrent miscarriages | Women with recurrent miscarriages undergoing hysteroscopy before IVF. Receives: Procedure: in-office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of endometrial hyperplasia
Measured: 12 months
Hormonal levels
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start2 Jan 2019
- Primary completion21 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pasquale De Franciscis, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965585
- Sponsor's protocol ID
- N.593
- Status last verified
- Apr 2023
- First submitted
- 21 May 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office Hysteroscopy in the Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
- ClinicalTrials.gov ID
- NCT03965585
- Acronym / sponsor ID
- N.593
- Conditions
- Infertility, Female, Endometrial Hyperplasia, PCOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 21 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Infertility | – | Procedure: in-office hysteroscopyWomen with a diagnosed primary infertility undergoing hysteroscopy before IVF. |
| Secondary Infertility | – | Procedure: in-office hysteroscopyWomen with a diagnosed secondary infertility undergoing hysteroscopy before IVF. |
| Recurrent miscarriages | – | Procedure: in-office hysteroscopyWomen with recurrent miscarriages undergoing hysteroscopy before IVF. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Southern Italian women eager for children who are set for infertility work-up at a tertiary university hospital
Key inclusion criteria (1 listed)
- Women undergoing office hysteroscopy prior to IVF techniques
Key exclusion criteria (1 listed)
- Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-office hysteroscopyin-office hysteroscopy with miniaturized instruments | Procedure or surgery | Primary Infertility, Recurrent miscarriages, Secondary Infertility |
Primary outcome
Prevalence of endometrial hyperplasia
Time frame: 12 months
Hormonal levels
Time frame: 12 months
1 secondary outcome
Operator's learning curve with cumulative summation test (questionnaire)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Endometrial Hyperplasia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of endometrial hyperplasia (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.