ACTRN12613001317785已完成2 期
A double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •Requiring first cycle of IVF or ICSI for infertility treatment
- •- Age between 18 and 45
- •- Undergoing a GnRH antagonist cycle (without OCP scheduling)
排除标准
- •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
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