None listed
Conditions
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.
Interventions
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. Fac
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.
Sponsors
NICM Health Research Institute, Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
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
Exclusion criteria
Breastfeeding within past 6 weeks Severe renal or hepatic disease
Outcome results
None listed