None listed
Conditions
Brief summary
The aim of this project is to determine whether melatonin supplementation has a dose response effect on clinical pregnancy rates, together with numerous important clinical, biochemical and sonographic secondary outcome measures. This will be achieved by a series of experiments designed to investigate the effect of melatonin on follicular fluid, serum, embryo and oocyte parameters as well as assessing clinical pregnancy rates and delivery rates
Interventions
This trial will have four arms. All capsules will be indistinguishable from each other.
1. Placebo capsule taken twice per day
2. 2mg melatonin capsule twice per day (4mg/d total)
3. 4mg melatonin capsule twice per day (8mg/d total)
4. 8mg melatonin capsule twice per day (16mg/d total)
The participant will commence taking the trial medication on the day that she begins ovarian stimulation injections (Day 2-3 of her natural menses) at 0800 and 2200 each day, with the last capsule being taken at
This trial will have four arms. All capsules will be indistinguishable from each other. 1. Placebo capsule taken twice per day 2. 2mg melatonin capsule twice per day (4mg/d total) 3. 4mg melatonin capsule twice per day (8mg/d total) 4. 8mg melatonin capsule twice per day (16mg/d total) The participant will commence taking the trial medication on the day that she begins ovarian stimulation injections (Day 2-3 of her natural menses) at 0800 and 2200 each day, with the last capsule being taken at 2200 the night before oocyte collection. Each participant will undergo an assisted reproductive technology as deemed appropriate by their treating clinician. Melatonin has a very short half-life. Consequently, no significant period of time is required for 'washout'. If a participant does not fall pregnant in her first trial cycle, she will be offered randomisation to a different treatment arm for her next cycle. In order to ensure the integrity of study data, participant adherence to trial protocol will be assessed on a medication administration record updated daily by the participant. At oocyte collection, participants will return medication bottles and compliance will be confirmed by counting remaining tablets. This will be recorded on individual patient compliance forms and patient record forms.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
- Requiring first cycle of IVF or ICSI for infertility treatment - Age between 18 and 45 - Undergoing a GnRH antagonist cycle (without OCP scheduling)
Exclusion criteria
1. Current untreated pelvic pathology – Stage 3 or 4 endometriosis, large submucosal uterine fibroids/polyps thought by the specialist to affect fertility, diagnosed current pelvic inflammatory disease, uterine malformations (i.e uterine didelphys, bicornuate uterus and septate uterus), Asherman's syndrome and the current diagnosis of a hydrosalpinx (not treated). 2. Currently enrolled in another investigational trial 3. Concurrent use of other adjuvant therapies (eg. Co Enzyme Q10, acupuncture) 4. Current pregnancy 5. Malignancy or other contraindication to IVF 6. Autoimmune disorders 7. Will not have regular blood tests with Monash IVF (because of distance from Monash IVF) 8. Undergoing preimplantation genetic diagnosis (PGD) 9. Hypersensitivity to melatonin or its metabolites 10. Concurrent use of any of the following medications a. Fluvoxamine (eg. Luvox, Movox, Voxam) b. Cimetidine (eg. Magicul, Tagamet) c. Quinolones and other CYP1A2 inhibitors (Ciprofloxacin, Avalox) d. Carbemazepine (eg. Tegretol), rifampicin (eg.Rifadin) and other CYP1A2 inducers e. Zolpidem (eg Stilnox), zopiclone (eg. Imovane) and other non-benzodiazepine hypnotics
Outcome results
None listed