None listed
Conditions
Brief summary
The Enhance study is a randomised placebo-controlled double-blind proof of concept clinical trial to analyse whether using a daily supplement can improve egg quality. Women between the age of 36 and 50years requiring IVF trying to conceive will be randomised for the use of NR at the dosage of 250mg, 1000mg, or placebo, once a day for six weeks before the trigger (36 hours before the egg collection) in an IVF cycle. A primary outcome will be analysing the number of day 5 blastocysts and secondary outcomes: number of oocytes retrieved, final estradiol level, fertilisation rates, number of embryos surviving to D3, pregnancy rates and outcomes, and NR safety. We will also be evaluating the bioavailability of NAD in blood and follicular fluid and oocyte quality.
Interventions
Patients who are eligible to join the study will be randomised into three groups. Women will be using NR - Nicotinamide Riboside (TRU NIAGEN - TGA listed ARTG number 328365), as oral capsules, at the dosage of 250mg, 1000mg or placebo once a day for six weeks before the trigger (36 hours before the egg collection) in an IVF treatment cycle. As a strategy to monitor adherence to the intervention, the research nurse will call each participant after 14 days of medication use to check for compliance
Patients who are eligible to join the study will be randomised into three groups. Women will be using NR - Nicotinamide Riboside (TRU NIAGEN - TGA listed ARTG number 328365), as oral capsules, at the dosage of 250mg, 1000mg or placebo once a day for six weeks before the trigger (36 hours before the egg collection) in an IVF treatment cycle. As a strategy to monitor adherence to the intervention, the research nurse will call each participant after 14 days of medication use to check for compliance. In addition, after the participant’s first clinic visit, (approximately 28 days since commencing the study medication), the participant will be seen by research staff to count their study medication to check for compliance.
Sponsors
University of New South Wales - UNSW
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
36 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
Female patients undergoing IVF aged greater than or equal to 36 years at the time of randomisation
Exclusion criteria
Consumption of herbal medicine or additional supplements except for preconception multivitamins
Outcome results
None listed