ClinicalTrials.gg
RecruitingNCT05042895Updated Nov 24, 2023

Hysteroscopic Findings in Ovarian Polycystic and Unexplained Infertile Women.

An interventional study of Group A and Group B in Infertility, sponsored by Woman's Health University Hospital, Egypt. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Woman's Health University Hospital, Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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:
02

Conditions studied

  • Infertility

Browse trials for

03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 150 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • for hysteroscopy or histopathology. e.g severe bleeding cervical stenosis.
  • Non infertility.
  • Adolescents and virgins.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    PCO women

    Group A will consist of 100 PCO infertile women

    Procedure: Group A

  • Active comparator
    unexplained infertile cases

    group B will consist of 50-unexplained infertility.

    Procedure: Group B

Interventions

  • ProcedureGroup 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.

    Also known as: Polycystic infertile women

  • ProcedureGroup 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.

    Also known as: Unexplained infertility

06

What researchers measure

Primary outcomes

  1. endometrial findings in polycystic and unexplained infertile women

    office hysteroscopy to assess endometrial thickness vascularity or any abnormal pathology.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05042895
Lead sponsor
Woman's Health University Hospital, Egypt
Responsible party
Professor Atef Darwish (Professor of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted
Sep 13, 2021
Start date
Aug 20, 2021
Primary completion
Sep 2, 2024 (estimated)
Completion
Dec 2, 2024 (estimated)
Last update
Nov 24, 2023

Study contacts

Atef mm Darwish
Contact
atef_darwish@yahoo.com
0201001572723
Atef mm Darwish
study director · Woman's Health University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion