Darwish Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Cases of Intrauterine Polyp(s)

NCT04367415 | Unknown

• 1 other identifier: Darwish test and polyp(s)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Anatomic Fallopian tubal patency and physiologic patency testing are feasible via hystertoscopy. This study aims to test the impact of different types of intrauterine polyp(s) on Darwish test (office hysteroscopic bubble suction test and tubal peristalsis).

Conditions

Intrauterine Polyp

Keywords

hysteroscopy; tubal patency; bubble suction test; tubal peristalsis; infertility; Abnormal uterine bleeding

Outcome Measures

Primary Outcomes (1)

• Anatomic and physiologic tubal patency (Office hysteroscopic bubble suction and tubal peristalsis) in cases of intrauterine polyp(s)

  diagnostic test

  1 year

Study Arms (2)

Normal uterine cavity on office hysteroscopy

If the uterine cavity is normal the patient will be allocated as group A.

Diagnostic Test: Darwish test for a free endometrial cavity; Diagnostic Test: Darwish test for an endometrial cavity with endometrial polyps

uterine cavity shown one or more polyps on office hysteroscopy

If there is one or more polyp(s) the patient will be allocated as group B. Localization and size estimation of the polyp(s) is mandatory.

Diagnostic Test: Darwish test for a free endometrial cavity; Diagnostic Test: Darwish test for an endometrial cavity with endometrial polyps

Interventions

Darwish test for a free endometrial cavity DIAGNOSTIC_TEST

Darwish test (Office hysteroscopic bubble suction and tubal peristalsis). If the uterine cavity is normal the patient will be allocated as group A

Normal uterine cavity on office hysteroscopy; uterine cavity shown one or more polyps on office hysteroscopy

Darwish test for an endometrial cavity with endometrial polyps DIAGNOSTIC_TEST

Darwish test (Office hysteroscopic bubble suction and tubal peristalsis).If there is one or more polyp(s) the patient will be allocated as group B.

Normal uterine cavity on office hysteroscopy; uterine cavity shown one or more polyps on office hysteroscopy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women with suspected intrauterine polyp(s)

You may qualify if:

• intrauterine polyp(s) as diagnosed by transvaginal ultrasonography (TVS) or saline infusion sonography (SIS).
• abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or postcoital bleeding,
• infertility.

You may not qualify if:

• A suspected pregnancy,
• heavy vaginal bleeding,
• active pelvic inflammatory disease (PID),
• severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (2)

Woman's Health University Hospital

Asyut, 71111, Egypt

RECRUITING

Woman's Health University Hospital

Asyut, 71111, Egypt

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Infertility; Metrorrhagia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Atef Darwish, MD PhD

CONTACT

0201001572723; atef_darwish@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: August 20, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 26, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

EG (2)