NCT05042895

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

May 23, 2021

Last Update Submit

November 21, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • endometrial findings in polycystic and unexplained infertile women

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

    1 year

Secondary Outcomes (1)

  • Access to Darwish hysteroscopic triad (DHT)

    1 year

Study Arms (2)

PCO women

ACTIVE COMPARATOR

Group A will consist of 100 PCO infertile women

Procedure: Group A

unexplained infertile cases

ACTIVE COMPARATOR

group B will consist of 50-unexplained infertility.

Procedure: Group B

Interventions

Group APROCEDURE

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
PCO women
Group BPROCEDURE

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
unexplained infertile cases

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Atef mm Darwish

    Woman's Health University Hospital

    STUDY DIRECTOR

Central Study Contacts

Atef mm Darwish

CONTACT

0201001572723atef_darwish@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A cross-sectional study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 23, 2021

First Posted

September 13, 2021

Study Start

August 20, 2021

Primary Completion

September 2, 2024

Study Completion

December 2, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

EG(1)