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

Phase 2

Completed

• Conditions: Infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12613001317785
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy rate - defined as the presence of a live pregnancy in the uterine cavity at a transvaginal ultrasound after approximately 7 weeks gestation[3 months after randomisation]