Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001310651
Ethics application status
Approved
Date submitted
21/09/2023
Date registered
15/12/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assisted Reproductive Technology in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders (ARTiMS) study. A prospective, longitudinal study.
Scientific title
Assisted Reproductive Technology use in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders (ARTiMS): A prospective, longitudinal study.
Secondary ID [1] 310658 0
MS200136_0086
Universal Trial Number (UTN)
Trial acronym
ARTiMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 331555 0
Multiple Sclerosis 331556 0
sub-fertility 332286 0
Neuromyelitis Optica Spectrum Disorders 332287 0
Condition category
Condition code
Neurological 328292 328292 0 0
Multiple sclerosis
Neurological 328561 328561 0 0
Other neurological disorders
Reproductive Health and Childbirth 328562 328562 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Very few studies have investigated the use of Assisted Reproductive Technology (ART) in Multiple Sclerosis (MS) or Neuomyelitis Optica Spectrum Disorders (NMOSD). It is not clear if there is an increase in disease activity after ART, and if there is, whether this is due to hormone treatment, failed cycles or the prolonged cessation of therapy. Additionally, there is currently no guidelines to manage sub-fertility in women with (ww) MS/NMOSD. The decision to cease therapy or not, and the subsequent period of time off treatment is not standardized and is best described as uncoordinated. Determining the key aspects of fertility treatment and MS treatment coordination may assist in developing a pathway for care of this growing cohort of wwMS/NMOSD, as well as provide opportunities to measure and treat hormone level variability and increased stress, anxiety, and depression.

This study will observe women who are planning to use some form of ART to fall pregnant over a three-year period. This will allow for two years to fall pregnant and at least 12 months follow up (into the first trimester post-partum for successful pregnancies.) We will assess blood based biomarkers to determine if there are indicators for both disease activity and pregnancy success.
Intervention code [1] 327064 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336144 0
The primary outcome is biomarkers of ART cycle success or failure in wwMS/NMOSD using a composite of many factors.
Timepoint [1] 336144 0
Baseline
prior to ART cycles (prior to ovarian stimulation and/or embryo transfer if using frozen embryos) (possibly multiple instances)
first trimester (8-14 weeks pregnant)
third trimester (32-36 weeks pregnant)
first trimester post-partum (8-12 weeks post deliver)
miscarriage (optional visit, to occur within 10 days of the miscarriage).
Secondary outcome [1] 427068 0
Identification of composite blood-based biomarkers that can predict relapse rate in wwMS/NMOSD while using ART to fall pregnant
Timepoint [1] 427068 0
Baseline
Prior to ART cycles (prior to ovarian stimulation and/or embryo transfer if using frozen embryos) (possibly multiple instances)
Secondary outcome [2] 427070 0
Evaluation of ART use on disease activity (relapse) during ART cycle use, during pregnancy and post-partum.
Timepoint [2] 427070 0
Baseline
prior to ART cycles (prior to ovarian stimulation and/or embryo transfer if using frozen embryos) (possibly multiple instances)
first trimester (8-14 weeks pregnant)
third trimester (32-26 weeks pregnant)
first trimester post-partum (8-12 weeks post delivery)
miscarriage (optional, 10 days post miscarriage)

Eligibility
Key inclusion criteria
Inclusion criteria are women who:
1) Have been diagnosed with MS or NMOSD
2) Who are planning to use ART to fall pregnant within 3 years of study start
3) Who attend one of the 8 MS specialist centres who use MSBase.
4) Who are >18 years of age and <55 years of age
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Women who fall pregnant by means other than ART.
2) Male genetic sex

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2024
Actual
29/04/2024
Date of last participant enrolment
Anticipated
29/09/2027
Actual
Date of last data collection
Anticipated
29/09/2028
Actual
Sample size
Target
25
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314877 0
Commercial sector/Industry
Name [1] 314877 0
Merck Healthcare Pty. Ltd
Country [1] 314877 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital of the Hunter New England Local Health District
Address
Dept. of Neurology, Lookout Road, New Lambton Heights NSW, 2310, Australia,
Country
Australia
Secondary sponsor category [1] 316875 0
None
Name [1] 316875 0
Address [1] 316875 0
Country [1] 316875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313875 0
Hunter New England Human Research and Ethics Committee
Ethics committee address [1] 313875 0
Ethics committee country [1] 313875 0
Australia
Date submitted for ethics approval [1] 313875 0
07/09/2022
Approval date [1] 313875 0
12/10/2022
Ethics approval number [1] 313875 0
2022ETH/01827

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129630 0
Prof Jeannette Lechner-Scott
Address 129630 0
John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
Country 129630 0
Australia
Phone 129630 0
+61 249213540
Fax 129630 0
Email 129630 0
[email protected]
Contact person for public queries
Name 129631 0
Vicki Maltby
Address 129631 0
John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW, 2305
Country 129631 0
Australia
Phone 129631 0
+61 240420283
Fax 129631 0
Email 129631 0
[email protected]
Contact person for scientific queries
Name 129632 0
Vicki Maltby
Address 129632 0
John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
Country 129632 0
Australia
Phone 129632 0
+61 240420283
Fax 129632 0
Email 129632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.