ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000561280

Ethics application status

Approved

Date submitted

26/12/2017

Date registered

13/04/2018

Date last updated

8/11/2022

Date data sharing statement initially provided

15/01/2019

Date results provided

22/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Relation between chronic endometritis and recurrent miscarriage

Scientific title

Relation between chronic endometritis and recurrent miscarriage

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic endometritis

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained recurrent miscarriage, after approval of the Obstetrics and Gynecology department of Ahmadi hospital. Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle, and endometrial biopsy for histological examination.
Studied women diagnosed with chronic endometritis during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, The endometrial biopsy will be cultured for the common infectious pathogens which include; Neisseria gonorrhea, Chlamydia trachomatis, Mycoplasma species, Ureaplasma urealyticum, and yeast at the endometrial levels.
Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle, with thorough evaluation of the endometrial mucosa.
Chronic endometritis defined as demonstration of micro-polyps that fluctuate in the cavity, stromal edema, and focal or diffuse hyperemia.
The surgeon will take an endometrial biopsy from studied women with evidence of chronic endometritis during hysteroscopic examination for histological examination. Studied women diagnosed with chronic endometritis during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, for cultural, and histological examinations.
Endometrial samples were diluted in 2 ml of saline, and divided into 2 samples, one for cultures, and the other placed in formalin for histological examination.

Timepoint [1]

Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,

Primary outcome [2]

Causative organism for chronic endometritis using culture for the endometrial samples taken during hysteroscopy.

Timepoint [2]

Results of endometrial culture takes about 3-5 days.

Secondary outcome [1]

None

Timepoint [1]

None

Eligibility

Key inclusion criteria

Patients and methods: Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained recurrent miscarriage, after approval of the Obstetrics and Gynecology department.
Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.

Minimum age

20 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria includes; family history of RM, uterine abnormalities, hormonal or metabolic disorders, severe male factor infertility, previous surgery for myoma and/or endometriosis, clinical or ultrasound diagnosis of endometriosis, known clinical autoimmune disease, anti-phospholipid syndrome (APS), thrombophilic condition requiring anticoagulant therapy, and unwilling to give informed consent.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2018

Actual

8/05/2018

Date of last participant enrolment

Anticipated

1/08/2019

Actual

3/08/2020

Date of last data collection

Anticipated

1/10/2019

Actual

1/10/2020

Sample size

Target

120

Accrual to date

Final

110

Recruitment outside Australia

Country [1]

Kuwait

State/province [1]

Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Address [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1]

Kuwait

Primary sponsor type

Hospital

Name

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Address

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Secondary sponsor category [1]

Individual

Name [1]

Ibrahim A. Abdelazim

Address [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1]

Kuwait

Secondary sponsor category [2]

Individual

Name [2]

Souad Al-Ajmi

Address [2]

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [2]

Kuwait

Secondary sponsor category [3]

Individual

Name [3]

Mohannad AbuFaza

Address [3]

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [3]

Kuwait

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Ethics committee address [1]

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Ethics committee country [1]

Kuwait

Date submitted for ethics approval [1]

18/12/2017

Approval date [1]

25/12/2017

Ethics approval number [1]

Summary

Brief summary

Background: A growing interest has been focused on the association between chronic endometritis (CE), and often asymptomatic inflammation of the endometrial lining and recurrent miscarriage (RM). Cicinelli et al, demonstrated that fluid hysteroscopy is a reliable technique for diagnosing chronic endometritis (CE) based on demonstrating specific signs such as micro polyps, stromal edema, and focal or diffuse hyperemia. Objectives: This prospective study designed to evaluate the relation between chronic endometritis, and recurrent miscarriage. 
Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained RM, after approval of the Obstetrics and Gynecology department of Ahmadi hospital. Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation. 
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle. During, hysteroscopies the uterine cavity will be explored through the panoramic view, with thorough evaluation of the endometrial mucosa. Chronic endometritis defined as demonstration of micro-polyps that fluctuate in the cavity, stromal edema, and focal or diffuse hyperemia. The surgeon will take an endometrial biopsy from studied women with evidence of chronic endometritis during hysteroscopic examination for histological examination. Studied women diagnosed with chronic endometritis (CE)  during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, The endometrial biopsy will be cultured for the common infectious pathogens which include; Neisseria gonorrhea, Chlamydia trachomatis, Mycoplasma species, Ureaplasma urealyticum, and yeast at the endometrial levels.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374198-CE and RM Protocol.doc (Protocol)

Attachments [2]

/AnzctrAttachments/374198-Approval letter of RM.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Ibrahim A. Abdelazim

Address

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

dr.ibrahimanwar@gmail.com

Contact person for public queries

Name

Ibrahim A. Abdelazim

Address

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

dr.ibrahimanwar@gmail.com

Contact person for scientific queries

Name

Ibrahim A. Abdelazim

Address

Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

dr.ibrahimanwar@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Line-byline data collected from each participant.

When will data be available (start and end dates)?

Start date 8/5/2018
End date 1/7/2019

Available to whom?

Anyone who is wishes to access it.

Available for what types of analyses?

Only to achieve the aims in the approved proposal.

How or where can data be obtained?

Principal investigator mail
dr.ibrahimanwar@gmail.com

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14177	Study protocol					374198-(Uploaded-15-04-2020-04-08-12)-Study-related document.doc

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Relation between chronic endometritis and recurrent miscarriage	2021	https://doi.org/10.5114/pm.2021.109769

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically