Hysteroscopic Findings in Ovarian Polycystic and Unexplained Infertile Women.

February 6, 2023 updated by: Professor Atef Darwish, Woman's Health University Hospital, Egypt

In many PCO infertile patients, abnormal endometrial echogenicity and thickness are documented by TVS and proved by endometrial biopsy in some cases. Should patients with normal appearance of the endometrium (echogenicity and thickness) by TVS require, endometrial biopsy remains controversial.

Therefore, if hysteroscopic examination demonstrates the endometrial pattern (echogenicity, vascularity, and thickness) in different PCO cases and correlates it to TVS and histopathology, this would recommend abstinence of endometrial curettage in some PCO patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim of the work The study aimed to evaluate post menstrual hysteroscopic findings in ovarian PCO and unexplained infertility and correlate them with TVS findings and final histopathologic diagnosis.

Methodology:

  1. Study design:

    A cross-sectional study.

  2. Setting: Infertility out-patient clinic, Outpatient ultrasonography unit and office hysteroscopy unit of the WWoman'sHealth University Hospital Assiut University.

  3. Patients:

    Infertile women in the reproductive age group (18-40 years) whether 1ry or 2ry.

  4. Grouping: it will include two groups of infertile women. Group A will consist of 100 PCO infertile women, while group B will consist of 50-unexplained infertility.

Sample size: the previous study could not find endometrial abnormalities hysteroscopy of women with PCOS using of rates. This study will use 100 women aiming to document more accurately the endometrial pattern in women with PCOS.

How is PCO diagnosed in this study? The diagnosis of PCO in this study will use the International evidence-based guideline for the assessment and management of PCOS 2018: The Rotterdam PCOS diagnostic criteria in adults (two of clinical or biochemical hyperandrogenism, ovulatory dysfunction, or polycystic ovaries on ultrasound) and where irregular menstrual cycles and hyperandrogenism are present, highlight that ultrasound is not necessary for diagnosis.

International Evidence-Based Guideline for the Assessment and Management of Polycystic Ovary Syndrome published in 2018 changed the ultrasound criteria from ≥12 to ≥20 antral follicles in an ovary to diagnose PCOS.

PCOS diagnosis is based on oligo-anovulation (OA), biochemical or clinical hyperandrogenism (HA), and polycystic ovary morphology (PCOM) on ultrasound extending across the original 1990 National Institutes of Health (NIH) criteria (OA and HA).

The 2003 Rotterdam criteria (any two of OA, HA, and PCOM) , and the Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society criteria (HA and OA or PCOM or both) .

The Rotterdam criteria are now widely accepted and generate four possible diagnostic PCOS phenotypes in adult women: (A) OA + HA + PCOM, (B) OA + HA, (C) HA + PCOM, and (D) OA + PCOM . The Rotterdam criteria are recommended and endorsed by the 2018 international PCOS evidence-based guideline, which was co-developed based on unprecedented evidence synthesis and best practice methods, by world-leading multidisciplinary clinicians and researchers across 37 societies from 71 countries, with consumer engagement .

Within eight years of menarche, both hyperandrogenism and ovulatory dysfunction are required, with ultrasound not recommended. Ultrasound criteria are tightened with advancing technology. Anti-Müllerian hormone levels are not yet adequate for diagnosis

Data collection:

Demographic data will be collected age, weight, BMI (weight [kg] divided by height in meters squared [m2]), obstetrics and gynecology history (duration of infertility and variability of menstrual cycles), and medications metformin, CC, and tamoxifen. .

TVS findings:

  1. International Evidence-Based Guideline for the Assessment and Management of Polycystic Ovary Syndrome published in 2018 Ovarian volume > 10 cm and ≥20antral follicles in an ovary
  2. Presence of ovulation or not,
  3. endometrial thickness and echognicity,

  4. anyadenxal or uterine abnormalities. Doppler U/S. whenever indicated e.g, endometrial mass lesion Hormonal profile assessment: Baseline day 3 serum FSH, LH, Prolactin, TSH. Pre ovulatory urinary LH will be done in all cases.

    Office hysteroscopic examination (2.6 telescopes and 3.2 mm outer sheath): assessment of the following:

    • cervical canal: arborvitae, mucous, any abnormal pathology like a polyp.
    • Endometrium cavity: vascularity, thickness, color, gland openings, any abnormal pathology.
    • Darwish hysterscopic triad: shape, caliber, depth, abnormal pathology, flow patency, bubble flow patency, and peristalsis.

    Endometrial sample by a Novak's curette Histopathologic assessment: will be sent for the routine out-patient Pathology lab to comment on the endometrial pattern and abnormalities.

    Physical and laboratory examinations follicle-stimulating hormone [FSH], LH, thyroid-stimulating hormone [TSH], prolactin, and pre ovulatory LH LH levels of the patients will be measured on day 3 of the menstrual cycle.

  5. Ethical considerations:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Woman's Health University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Reproductive age (18-40).
  2. Infertility: 1ry or 2ry.
  3. No contraindication for hysteroscopy or histopathology. e.g severe bleeding cervical stenosis.
  4. Postmenstrual.

Exclusion Criteria:

  • contraindication for hysteroscopy or histopathology. e.g severe bleeding cervical stenosis.
  • Non infertility.
  • Adolescents and virgins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: PCO women
Group A will consist of 100 PCO infertile women
Procedure: Group A

Office diagnostic hysteroscopy for assessment of the following:

  • cervical canal: arborvitae, mucous, any abnormal pathology like a polyp.
  • Endometrium cavity: vascularity, thickness, color, gland openings, any abnormal pathology.
  • Darwishhysterscopic triad: shape, caliber, depth, abnormal pathology, flow patency, bubble flow patency, and peristalsis.

Endometrial sample by a Novak's curette Histopathologic assessment: will be sent for the routine out-patient Pathology lab to comment on the endometrial pattern and abnormalities.

Physical and laboratory examinations follicle-stimulating hormone [FSH], LH, thyroid-stimulating hormone [TSH], prolactin, and pre ovulatory LH LH levels of the patients will be measured on day 3 of the menstrual cycle.

Other Names:
  • Polycystic infertile women
ACTIVE_COMPARATOR: unexplained infertile cases
group B will consist of 50-unexplained infertility.
Procedure: Group B

Office diagnostic hysteroscopy for assessment of the following:

  • cervical canal: arborvitae, mucous, any abnormal pathology like a polyp.
  • Endometrium cavity: vascularity, thickness, color, gland openings, any abnormal pathology.
  • Darwishhysterscopic triad: shape, caliber, depth, abnormal pathology, flow patency, bubble flow patency, and peristalsis.

Endometrial sample by a Novak's curette Histopathologic assessment: will be sent for the routine out-patient Pathology lab to comment on the endometrial pattern and abnormalities.

Physical and laboratory examinations follicle-stimulating hormone [FSH], LH, thyroid-stimulating hormone [TSH], prolactin, and pre ovulatory LH LH levels of the patients will be measured on day 3 of the menstrual cycle.

Other Names:
  • Unexplained infertility

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
endometrial findings in polycystic and unexplained infertile women
Time Frame: 1 year
office hysteroscopy to assess endometrial thickness vascularity or any abnormal pathology.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Access to Darwish hysteroscopic triad (DHT)
Time Frame: 1 year
DHT: a conical area just proximal to the endometrial cavity, its base is the ostium, walls are converging intramural parts of the Fallopian tubes and summit is the narrowist part of the Fallopian tube.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Woman's Health University Hospital, Egypt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Atef mm Darwish, Woman's Health University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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