RecruitingACTRN12623001310651

Assisted Reproductive Technology in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders (ARTiMS) study. A prospective, longitudinal study.

Assisted Reproductive Technology use in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders (ARTiMS): A prospective, longitudinal study.


Sponsor

John Hunter Hospital of the Hunter New England Local Health District

Enrollment

25 participants

Start Date

Apr 29, 2024

Study Type

Observational

Conditions

Summary

Very few studies have investigated the use of Assisted Reproductive Technology (ART), such as in vitro fertilization (IVF), in multiple sclerosis (MS) or Neuromyelitis optica spectrum disorders (NMOSD). This study will provide a comprehensive overview of ART use in women with MS or NMOSD and look at if ART affects disease activity, if MS or NMOSD affects a woman's ability to fall pregnant through ART. Additionally we plan to evaluate blood based tests that might be able to predict both ART success or increased disease activity in women with MS or NMOSD while using ART.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

Multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) are neurological conditions that affect more women than men and often occur during reproductive years. Many women with these conditions want to start a family and turn to assisted reproductive technology (ART) such as IVF when natural conception proves difficult. However, very little is known about how ART affects disease activity in MS or NMOSD, or how these conditions affect the success of ART. The ARTiMS study is a prospective, observational study following women with MS or NMOSD who are planning to use ART to conceive. It will track disease activity before, during, and after ART cycles, and look at pregnancy success rates. The study will also evaluate blood tests that might predict both IVF success and the risk of disease relapse — potentially allowing for smarter, safer treatment planning. To be eligible, you must be a woman aged 18–55 who has been diagnosed with MS or NMOSD, is planning to use ART within the next 3 years, and attends one of the 8 participating MS specialist centres in Australia. Women who become pregnant by means other than ART are not included.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 incre

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.


Locations(1)

NSW,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12623001310651


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