Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001769875
Ethics application status
Approved
Date submitted
26/11/2021
Date registered
23/12/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
23/12/2021
Date results information initially provided
19/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A preliminary trial to test methodology of an RCT of adjunct naturopathy for pregnancy rates in women with diminished ovarian reserve
Scientific title
Effectiveness of adjunct naturopathy for pregnancy rates in women with diminished ovarian reserve compared to usual care alone: feasibility of a randomised controlled trial
Secondary ID [1] 305845 0
None
Universal Trial Number (UTN)
Trial acronym
NatDOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diminished ovarian reserve 324385 0
Infertility 324386 0
Condition category
Condition code
Alternative and Complementary Medicine 321868 321868 0 0
Herbal remedies
Reproductive Health and Childbirth 321869 321869 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A complex intervention of whole-system naturopathic practice including:
- 4 naturopathic consultations over 16 weeks (an initial consultation of 75 minutes and 3 consultations of 45 minutes every 4-6 weeks as recommended by the naturopath); consultations will be conducted as naturopaths practice in the community within Australia: Naturopathic management of women with DOR is complex and individualised incorporating general health and social factors that influence reproductive health outcomes. Factors that are often considered include reproductive and family history, stress management, sympathetic-parasympathetic tone, endocrine function, assimilation of nutrition and evacuation of metabolic and toxic substances. Naturopaths aim to foster lifestyle oriented self-care; and provide preventive, health promotion within the capacity and resources of individuals. Treating naturopaths may provide diet, lifestyle, counselling and education including self-care according to naturopathic principles. This will vary depending on the clinical presentation of the participant.
- an individualised selection of up to 5 nutritional supplements (Eagle Tresos Natal 1 tablet daily, Eagle Vital Pure Omega-3 1 - 6 capsules daily, Mediherb Ubiquinol Forte 300mg 1 - 2 capsules daily, Mediherb Vitamin D spray 1,000 - 2,000 IU daily, Orthoplex Zinc 30mg 1 - 2 capsules daily)
- individualised herbal medicine formula as a liquid solution from MediHerb herbal extracts: shatavari, dong quai, black cohosh, cinnamon, turmeric, wild yam, ginkgo, licorice, peony, rehmannia, chamomile, tribulus, vitex, withania, ginger. The herbal medicine formula will vary depending on the clinical presentation of the participant.
Dosage for daily oral administration will be prescribed by the practitioner for 16 weeks.
Compliance to the prescribed intervention will be monitored in a weekly survey and at each consultation by the practitioner. At the end of intervention, all supplement bottles (including empty containers) will be returned to the research team for accountability.
Intervention code [1] 322296 0
Treatment: Other
Comparator / control treatment
Routine nutritional supplements recommended for pregnancy:
- Orthoplex Iodine (225mcg/cap)
- Orthoplex Folinic acid (500mcg/cap)
One tablet of each for daily oral administration for 16
Compliance to the prescribed intervention will be monitored in a weekly survey and at midpoint (Week 8) by the research team. At the end of intervention, all supplement bottles (including empty containers) will be returned to the research team for accountability.
Control group
Active

Outcomes
Primary outcome [1] 329628 0
To evaluate feasibility of the RCT (recruitment and retention rate) via audit of study enrolment logs and case report forms
Timepoint [1] 329628 0
Cumulative data will be assessed at the completion of the study
Primary outcome [2] 329863 0
To evaluate acceptability of RCT by a composite of adherence rate (attendance of naturopathic consultations and compliance with intervention) via Weekly Safety & Compliance survey (2-item survey designed by the research team) and acceptability via Participant Satisfaction Questionnaire (8-item validated Client Satisfaction Questionnaire (CSQ-8))
Timepoint [2] 329863 0
Cumulative data will be assessed at the completion of the study.
Primary outcome [3] 329864 0
Safety of the intervention (frequency and severity of adverse events) via Weekly Safety & Compliance survey (2-item survey designed by the research team)
Timepoint [3] 329864 0
Cumulative data will be assessed at the completion of the study
Secondary outcome [1] 403215 0
To explore pregnancy outcomes (a composite secondary outcome) including pregnancy rates
via de-identified medical reports, pregnancy losses and reason, pregnancy to full-term (gestation age, maternal complications, birth weight, delivery type) via telephone survey of participants.
Timepoint [1] 403215 0
Monthly (or each menstrual cycle) from enrolment to Week 16 post-enrolment (intervention completion) and 3 months post-intervention completion. Participants that are pregnant at Week 16 post-enrolment will be followed up at full-term.
Secondary outcome [2] 403216 0
To explore any changes in menstrual cycle regularity via period tracker application
Timepoint [2] 403216 0
Monthly (or each menstrual cycle) from enrolment to Week 16 post-enrolment.
Secondary outcome [3] 403550 0
To explore any changes in mental health via the 21 item Depression Anxiety Stress Scale (DASS-21)
Timepoint [3] 403550 0
Baseline, Week 16 post-enrolment
Secondary outcome [4] 403551 0
To explore any changes in fertility-related quality of life via the Fertility Quality of Life (FertiQOL) questionnaire
Timepoint [4] 403551 0
Baseline, Week 16 post-enrolment
Secondary outcome [5] 403552 0
To explore any changes in the quality of diet via the DIetary Guideline Index for Australian Adults (DGI-AD)
Timepoint [5] 403552 0
Baseline, Week 16 post-enrolment
Secondary outcome [6] 403553 0
To explore any changes in physical activity via the International Physical Activity (IPAQ) short form
Timepoint [6] 403553 0
Baseline, Week 16 post-enrolment
Secondary outcome [7] 403554 0
To explore any changes in sleep quality via the Pittsburg Sleep Quality Index (PSQI)
Timepoint [7] 403554 0
Baseline, Week 16 post-enrolment
Secondary outcome [8] 403555 0
To explore any changes in anthropometric measures via self-reported body weight
Timepoint [8] 403555 0
Baseline, Week 16 post-enrolment
Secondary outcome [9] 404098 0
To explore any changes in anthropometric measures via self-reported waist circumference
Timepoint [9] 404098 0
Baseline, Week 16 post-enrolment

Eligibility
Key inclusion criteria
Clinical diagnosis of diminished ovarian reserve - one or more of the following:
o elevated basal (day 2-5) follicle-stimulating hormone (FSH) levels of > 10 IU/L
o Anti-mullerian hormone (AMH) < 1.1 ng/ml or 7.85 pmol/L or in age-specific lowest quartile (< 10%)
o Antral follicle count (AFC) < 5-7 follicles
o < 4 oocytes retrieved in a previous in vitro fertilisation (IVF) stimulated cycle
Trying to conceive
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Breastfeeding within past 6 weeks
Severe renal or hepatic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This trial is not designed to establish efficacy but rather to assess feasibility. Baseline demographics and primary feasibility outcomes will be reported using counts and percentages for categorical variables and means and standard deviations for continuous variables.An exploratory analysis of secondary outcomes will compare differences between groups for pregnancy outcomes as differences and changes in DASS-21, FertiQol, DGI-AD, IPAQ, PSQI, anthropometric measures as mean differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2022
Actual
2/04/2022
Date of last participant enrolment
Anticipated
27/03/2023
Actual
9/08/2022
Date of last data collection
Anticipated
27/10/2023
Actual
14/08/2023
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310201 0
Charities/Societies/Foundations
Name [1] 310201 0
The Jacka Foundation of Natural Therapies
Country [1] 310201 0
Australia
Primary sponsor type
University
Name
NICM Health Research Institute, Western Sydney University
Address
Western Sydney University Westmead Campus
158-160 Hawkesbury Road,
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 311294 0
None
Name [1] 311294 0
Address [1] 311294 0
Country [1] 311294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309882 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 309882 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 309882 0
Australia
Date submitted for ethics approval [1] 309882 0
25/11/2021
Approval date [1] 309882 0
15/02/2022
Ethics approval number [1] 309882 0

Summary
Brief summary
In Australia, one in 6 couples will have difficulty conceiving a baby. Diminished ovarian reserve (DOR) lowers the chance of pregnancy even more. The best way to assist women with DOR is unclear as there are few helpful treatments available. Many women in Australia use naturopathy to improve their chances of getting pregnant and having a healthy baby. However, there is no rigorous evidence that can tell us if naturopathy is effective or safe for women with DOR. We are also interested in the possible role of naturopathy as an additional treatment to increase pregnancy rates in women with DOR.
To answer this question, we will need to first check that rigorous clinical trial methodology is acceptable to women with DOR and, if it is, to follow up with a larger clinical trial. Prior to embarking on such a large and expensive study, we propose to do a small, preliminary study to see if women with DOR are interested in participating in clinical research of naturopathy, and gather preliminary safety data. We have completed a survey with women with DOR which has informed the design of this study; and a survey and focus group to ensure the naturopathic management being evaluated is close to that which is provided by naturopaths when they support women with DOR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115714 0
Dr Carolyn Ee
Address 115714 0
NICM Health Research Institute
Western Sydney University Westmead Campus
158-160 Hawkesbury Road, Westmead NSW 2145
Country 115714 0
Australia
Phone 115714 0
+61 413 319830
Fax 115714 0
Email 115714 0
c.ee@westernsydney.edu.au
Contact person for public queries
Name 115715 0
Ms Alison Maunder
Address 115715 0
NICM Health Research Institute
Western Sydney University Westmead Campus
158-160 Hawkesbury Road, Westmead NSW 2145
Country 115715 0
Australia
Phone 115715 0
+61 417 800355
Fax 115715 0
Email 115715 0
a.maunder2@westernsydney.edu.au
Contact person for scientific queries
Name 115716 0
Ms Alison Maunder
Address 115716 0
NICM Health Research Institute
Western Sydney University Westmead Campus
158-160 Hawkesbury Road, Westmead NSW 2145
Country 115716 0
Australia
Phone 115716 0
+61 417 800355
Fax 115716 0
Email 115716 0
alison.maunder@westernsydney.edu.au

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.