NCT04357054

Brief Summary

This study aims to test the impact of different types of liomyoma on Darwish test (hysteroscopic bubble suction test and tubal peristalsis of Darwish triad ) in women subjected to postmenstrual combined laparoscopy and hysteroscopy.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
2.9 years until next milestone

Study Start

First participant enrolled

March 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

April 19, 2020

Last Update Submit

February 6, 2023

Conditions

Tubal Patency and Peristalsis During Hysteroscopy

Keywords

hysteroscopytubal patencybubble suction testtubal peristalsisliomyomaDarwish test

Outcome Measures

Primary Outcomes (1)

  • positive bubble suction and tubal peristalsis (Darwish test) in women with myomata and those without.

    Diagnostic tubal patency test via hysteroscopy

    1 month

Study Arms (2)

Normal uterus

ACTIVE COMPARATOR

Darwish test

Diagnostic Test: Darwish test

Myomatous uterus

ACTIVE COMPARATOR

Darwish test

Diagnostic Test: Darwish test

Interventions

Darwish testDIAGNOSTIC_TEST

Infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.

Also known as: hysteroscopic bubble suction and tubal peristalsis of Darwish triad
Myomatous uterusNormal uterus

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Woman's Health University Hospital

Asyut, 71111, Egypt

RECRUITING

Woman's Health University Hospital

Asyut, 71111, Egypt

RECRUITING

Central Study Contacts

Atef Darwish

CONTACT

0201001572723atef_darwish@yahoo.com

Atef MM Darwish, Prof

CONTACT

0201001572723atef_darwish@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: hysteroscopic bubble suction and tubal peristalsis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

March 5, 2023

Primary Completion

May 23, 2023

Study Completion

May 25, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)