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Hysteroscopic Findings in Ovarian Polycystic and Unexplained Infertile Women.

Primary Purpose

Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Woman's Health University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PCO women

unexplained infertile cases

Arm Description

Group A will consist of 100 PCO infertile women

group B will consist of 50-unexplained infertility.

Outcomes

Primary Outcome Measures

endometrial findings in polycystic and unexplained infertile women
office hysteroscopy to assess endometrial thickness vascularity or any abnormal pathology.

Secondary Outcome Measures

Access to Darwish hysteroscopic triad (DHT)
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.

Full Information

First Posted
May 23, 2021
Last Updated
February 6, 2023
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05042895
Brief Title
Hysteroscopic Findings in Ovarian Polycystic and Unexplained Infertile Women.
Official Title
Hysteroscopic Findings in Ovarian Polycystic and Unexplained Infertile Women.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Study design: A cross-sectional study. Setting: Infertility out-patient clinic, Outpatient ultrasonography unit and office hysteroscopy unit of the WWoman'sHealth University Hospital Assiut University. Patients: Infertile women in the reproductive age group (18-40 years) whether 1ry or 2ry. 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: 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 Presence of ovulation or not, endometrial thickness and echognicity, 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. Ethical considerations:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A cross-sectional study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCO women
Arm Type
Active Comparator
Arm Description
Group A will consist of 100 PCO infertile women
Arm Title
unexplained infertile cases
Arm Type
Active Comparator
Arm Description
group B will consist of 50-unexplained infertility.
Intervention Type
Procedure
Intervention Name(s)
Group A
Other Intervention Name(s)
Polycystic infertile women
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group B
Other Intervention Name(s)
Unexplained infertility
Intervention Description
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.
Primary Outcome Measure Information:
Title
endometrial findings in polycystic and unexplained infertile women
Description
office hysteroscopy to assess endometrial thickness vascularity or any abnormal pathology.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Access to Darwish hysteroscopic triad (DHT)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Reproductive age (18-40). Infertility: 1ry or 2ry. No contraindication for hysteroscopy or histopathology. e.g severe bleeding cervical stenosis. Postmenstrual. Exclusion Criteria: contraindication for hysteroscopy or histopathology. e.g severe bleeding cervical stenosis. Non infertility. Adolescents and virgins.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atef mm Darwish
Phone
0201001572723
Email
atef_darwish@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef mm Darwish
Organizational Affiliation
Woman's Health University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Woman's Health University Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atef MM Darwish, MD PhD
Phone
0201001572723
Email
atef_darwish@yahoo.com

12. IPD Sharing Statement

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Hysteroscopic Findings in Ovarian Polycystic and Unexplained Infertile Women.

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