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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
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Scientific title
Relation between chronic endometritis and recurrent miscarriage
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Secondary ID [1]
293649
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic endometritis
305936
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Condition category
Condition code
Reproductive Health and Childbirth
305130
305130
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0
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Antenatal care
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Reproductive Health and Childbirth
305131
305131
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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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,
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Intervention code [1]
299910
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Diagnosis / Prognosis
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
304285
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Timepoint [1]
304285
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Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,
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Primary outcome [2]
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Causative organism for chronic endometritis using culture for the endometrial samples taken during hysteroscopy.
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Assessment method [2]
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Timepoint [2]
304789
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Results of endometrial culture takes about 3-5 days.
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Secondary outcome [1]
341503
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None
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Assessment method [1]
341503
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Timepoint [1]
341503
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None
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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.
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Minimum age
20
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2018
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Actual
8/05/2018
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Date of last participant enrolment
Anticipated
1/08/2019
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Actual
3/08/2020
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Date of last data collection
Anticipated
1/10/2019
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Actual
1/10/2020
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Sample size
Target
120
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Accrual to date
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Final
110
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Recruitment outside Australia
Country [1]
9454
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Kuwait
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State/province [1]
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Ahmadi hospital, Ahmadi, Kuwait.
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Funding & Sponsors
Funding source category [1]
298266
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Hospital
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Name [1]
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Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
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Address [1]
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Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country [1]
298266
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Kuwait
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Primary sponsor type
Hospital
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Name
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
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Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country
Kuwait
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Secondary sponsor category [1]
297382
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Individual
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Name [1]
297382
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Ibrahim A. Abdelazim
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Address [1]
297382
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Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country [1]
297382
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Kuwait
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Secondary sponsor category [2]
297383
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Individual
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Name [2]
297383
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Souad Al-Ajmi
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Address [2]
297383
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Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country [2]
297383
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Kuwait
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Secondary sponsor category [3]
297384
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Individual
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Name [3]
297384
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Mohannad AbuFaza
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Address [3]
297384
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Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country [3]
297384
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Kuwait
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299268
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Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
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Ethics committee address [1]
299268
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Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Ethics committee country [1]
299268
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Kuwait
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Date submitted for ethics approval [1]
299268
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18/12/2017
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Approval date [1]
299268
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25/12/2017
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Ethics approval number [1]
299268
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
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/AnzctrAttachments/374198-CE and RM Protocol.doc
(Protocol)
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Attachments [2]
2305
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/AnzctrAttachments/374198-Approval letter of RM.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
79850
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Prof Ibrahim A. Abdelazim
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Address
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Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country
79850
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Kuwait
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Phone
79850
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+965-66551300
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Fax
79850
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Email
79850
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[email protected]
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Contact person for public queries
Name
79851
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Ibrahim A. Abdelazim
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Address
79851
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Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country
79851
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Kuwait
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Phone
79851
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+965-66551300
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Fax
79851
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Email
79851
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[email protected]
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Contact person for scientific queries
Name
79852
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Ibrahim A. Abdelazim
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Address
79852
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Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
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Country
79852
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Kuwait
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Phone
79852
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+965-66551300
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Fax
79852
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Email
79852
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Line-byline data collected from each participant.
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When will data be available (start and end dates)?
Start date 8/5/2018
End date 1/7/2019
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Available to whom?
Anyone who is wishes to access it.
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Available for what types of analyses?
Only to achieve the aims in the approved proposal.
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How or where can data be obtained?
Principal investigator mail
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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