CompletedPhase 2Phase 3ACTRN12613001317785

MIART: Can melatonin improve the live birth rate in infertile couples undergoing assisted reproductive technologies?

A double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART)

Sponsor

Monash University

Enrollment

160 participants

Start Date

Sep 1, 2014

Study Type

Interventional

Conditions

Infertility

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

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria3

Requiring first cycle of IVF or ICSI for infertility treatment
Age between 18 and 45
Undergoing a GnRH antagonist cycle (without OCP scheduling)

Exclusion Criteria15

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).
Currently enrolled in another investigational trial
Concurrent use of other adjuvant therapies (eg. Co Enzyme Q10, acupuncture)
Current pregnancy
Malignancy or other contraindication to IVF
Autoimmune disorders
Will not have regular blood tests with Monash IVF (because of distance from Monash IVF)
Undergoing preimplantation genetic diagnosis (PGD)
Hypersensitivity to melatonin or its metabolites
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

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.