Melatonin in Assisted Reproductive Technology: A Pilot Double-Blind Randomized Placebo-Controlled Clinical Trial

Frontiers in Endocrinology

Nicholas Lolatgis²  Mark Lawrence²  Anthony Lawrence²  Philip Thomas²  Melissa Wong²  Chris Russell²  Luk Rombauts²  Beverley Vollenhoven²  Kenneth Leong²  Nicole Hope²  Shavi Fernando³  Euan Morrison Wallace³ 

[1] Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia;Monash IVF, Richmond, VIC, Australia;The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia;

关键词: melatonin;    Assisted Reproductive Technology;    ART;    in-vitro fertilization;    IVF;    clinical pregnancy;   

DOI  :  10.3389/fendo.2018.00545

来源: DOAJ

【 摘 要 】

Purpose: To explore in a small pilot study whether oral melatonin, administered during ovarian stimulation increases clinical pregnancy rate (CPR) after IVF and what dose might be most effective.Methods: Pilot double-blind, dose-finding, placebo-controlled randomized clinical trial in private IVF clinics in Australia between September 2014 and September 2016. One hundred and sixty women having their first cycle of IVF or ICSI were randomized to receive placebo (n = 40), melatonin 2 mg (n = 41), melatonin 4 mg (n = 39), or melatonin 8 mg (n = 40) twice per day (BD) during ovarian stimulation. The primary outcome was CPR. Secondary outcomes included serum and follicular fluid (FF) melatonin concentrations, oocyte/embryo quantity/quality, and live birth rate (LBR). Analysis was performed using the intention-to-treat principle.Results: There was no difference in CPR or LBR between any of the four groups (p = 0.5). When all the doses of melatonin were compared as a group with placebo, the CPR was 21.7% for the former and 15.0% for the latter [OR 1.57 (95% CI 0.59, 4.14), p = 0.4]. There were also no differences between the groups in total oocyte number, number of MII oocytes, number of fertilized oocytes, or the number or quality of embryos between the groups. This is despite mean FF melatonin concentration in the highest dose group (8 mg BD) being nine-fold higher compared with placebo (P < 0.001).Conclusion: No significant differences were observed in CPR or oocyte and embryo parameters despite finding a nine-fold increase in FF melatonin concentration. However, this study was not sufficiently powered to assess differences in CPR and therefore, these results should be interpreted with caution. Because this was a small RCT, a beneficial effect of melatonin on IVF pregnancy rates cannot be excluded and merits confirmation in further, larger clinical trials. ANZCTR (http://www.anzctr.org.au/ Project ID: ACTRN12613001317785).

【 授权许可】

Unknown