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出境医 / 临床实验 / Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Infertility, Female Endometrial Hyperplasia PCOS | Procedure: in-office hysteroscopy |
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
| Study Type : | Observational |
| Actual Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Office Hysteroscopy in the Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women |
| Actual Study Start Date : | January 2, 2019 |
| Actual Primary Completion Date : | April 21, 2019 |
| Actual Study Completion Date : | April 30, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Primary Infertility
Women with a diagnosed primary infertility undergoing hysteroscopy before IVF.
|
Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments
|
|
Secondary Infertility
Women with a diagnosed secondary infertility undergoing hysteroscopy before IVF.
|
Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments
|
|
Recurrent miscarriages
Women with recurrent miscarriages undergoing hysteroscopy before IVF.
|
Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments
|
Outcome Measures
Primary Outcome Measures :
- Prevalence of endometrial hyperplasia [ Time Frame: 12 months ]
- Hormonal levels [ Time Frame: 12 months ]
Secondary Outcome Measures :
- Operator's learning curve with cumulative summation test (questionnaire) [ Time Frame: 12 months ]assess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM).
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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
Criteria
Inclusion Criteria:
- Women undergoing office hysteroscopy prior to IVF techniques
Exclusion Criteria:
- Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)
Contacts and Locations
Locations
| Italy | |
| Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli" | |
| Naples, Italy, 80138 | |
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 21, 2019 | ||||
| First Posted Date | May 29, 2019 | ||||
| Last Update Posted Date | May 29, 2019 | ||||
| Actual Study Start Date | January 2, 2019 | ||||
| Actual Primary Completion Date | April 21, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Operator's learning curve with cumulative summation test (questionnaire) [ Time Frame: 12 months ] assess the learning curve (LC) using cumulative summation test for learning curve (LC-CUSUM).
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women | ||||
| Official Title | Office Hysteroscopy in the Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition |
|
||||
| Intervention | Procedure: in-office hysteroscopy
in-office hysteroscopy with miniaturized instruments
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
100 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | April 30, 2019 | ||||
| Actual Primary Completion Date | April 21, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender | Not Provided | ||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03965585 | ||||
| Other Study ID Numbers | N.593 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli" | ||||
| Study Sponsor | University of Campania "Luigi Vanvitelli" | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University of Campania "Luigi Vanvitelli" | ||||
| Verification Date | May 2019 | ||||
