Pilehvari Shamim, Yavangui Mahnaz, Paknahad Elham, Cheraghi Zahra, Ghorbani Marzieh
Clinical Research Development Unit of Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.
Endometrium and Endometriosis Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.
Chonnam Med J. 2023 Sep;59(3):188-193. doi: 10.4068/cmj.2023.59.3.188. Epub 2023 Sep 25.
Polycystic ovary syndrome (PCOS) is one of the most critical disorders, which affects approximately 20% of women of childbearing age and melatonin supplementation in these women can be effective. However, human studies in this area are particularly limited to IVF candidates. The aim of this clinical trial study was to evaluate the effect of melatonin on the in vitro fertilization (IVF) in PCOS involved women. In this clinical trial study, a total of 320 women with PCOS were randomly assigned to the intervention and control groups. Patients in the intervention group (n=160) received a combination of melatonin and metformin (3 mg and 500 mg, respectively) three times a day. The control group (n=160) received metformin 500 mg from the luteal phase of the cycle before the start of gonadotropin. Oocyte and embryo quality, number of oocytes, and pregnancy outcomes were compared in both groups. Our study revealed that the frequency of Metaphase II oocytes (69.9% vs. 57.9%, p<0.001) and the number of embryos of the top-quality (grade A) were higher in the group treated with melatonin (40.3% vs. 29.9%, p=0.001). The rate of clinical pregnancy and implantation were also higher in the intervention group. The odds of clinical pregnancy in the intervention group was 1.8 times (p=0.039). Moreover, oral melatonin supplementation was effective in patients with PCOS, who were candidates for IVF because of the increased quality of mature oocytes, top-quality embryos, and increased odds of clinical pregnancy.
多囊卵巢综合征（PCOS）是最严重的疾病之一，影响着约20%的育龄妇女，对这些女性补充褪黑素可能有效。然而，该领域的人体研究特别局限于体外受精（IVF）候选者。这项临床试验研究的目的是评估褪黑素对患有PCOS的女性进行体外受精（IVF）的影响。在这项临床试验研究中，共有320名PCOS女性被随机分配到干预组和对照组。干预组（n = 160）的患者每天三次接受褪黑素和二甲双胍的联合用药（分别为3毫克和500毫克）。对照组（n = 160）在促性腺激素开始使用前的周期黄体期接受500毫克二甲双胍。比较两组的卵母细胞和胚胎质量、卵母细胞数量和妊娠结局。我们的研究表明，在接受褪黑素治疗的组中，中期II卵母细胞的频率（69.9%对57.9%，p<0.001）和优质（A级）胚胎的数量更高（40.3%对29.9%，p = 0.001）。干预组的临床妊娠率和着床率也更高。干预组临床妊娠的几率是对照组的1.8倍（p = 0.039）。此外，口服补充褪黑素对因成熟卵母细胞质量提高、优质胚胎增加以及临床妊娠几率增加而成为IVF候选者的PCOS患者有效。
