Comparison of IVF Outcome and Endometrium Effect in Infertility Patients Between Diminished and Normal Ovarian Reserve After Melatonin Administration.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- IVF outcome - clinical pregnancy rate
研究概览
简要总结
Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn may decrease the reproductive function. Many researchers have already proven improvement on reproductive function after antioxidant (melatonin) administration. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.
详细描述
Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn may decrease the reproductive function. Many researchers have already proven improvement on reproductive function after antioxidant (melatonin) administration. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.
This is an randomized controlled trial to evaluate the effect of melatonin to improve the quality of sleep and reduce the oxidative stress. 100 patients will be randomized in to two groups, the one with melatonin administration for 2 weeks and the other with placebo administration. Each group will be composed of 2 sub groups, poor responders and normal responders.
Then the serum and the follicular fluid will be collected at the time of oocyte retrieval and melatonin concentration oxidative stress marker will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertility patients visiting Bundang CHA hospital between the age of 20 to
- •Currently, not being treated for any gynecological or medical diseases.
排除标准
- •Current untreated pelvic pathology (moderate-to-severe endometriosis, submucosal uterine fibroids/polyps assessed by the treating specialist to affect fertility, pelvic inflammatory disease,uterine malformations, and hydrosalpinx.)
- •Currently enrolled in another interventional clinical trial.
- •Concurrent use of other adjuvant therapies (e.g.Chinese herbs, acupuncture).
- •Autoimmune disorders.
- •Undergoing preimplantation genetic diagnosis.
- •Concurrent use of any of the following medications (Fluvoxamine,Cimetidine, Quinolones, Carbamazepine, rifampicin,Zolpidem, zopiclone, and other non-benzodiazepine hypnotic, other CYP1A2 inducers.
- •Genetic disorders regarding galactose intolerance, lactase deficiency, glucose-galactose malabsorption
- •Inability to comply with trial protocol.
研究组 & 干预措施
melatonin administration group
Total 50 patients are to be randomized into this group, 25 of which are poor responder and the others are normal responders. After randomization, participants are to under go melatonin administration intervention from the time of controlled ovarian hyperstimulation(COH) to the date of oocyte retrieval. If pregnancy is not confirmed in the first cycle, all subjects are to enter the second cycle after 1-2 months of recovery period.
For the second cycle, the procedure will be repeated same as the first cycle with doubling of the drug dosage . It should also be administered for 2 weeks until the date of oocyte retrieval.
干预措施: Melatonin adminstration (Drug)
placebo comparator
Total 50 patients are to be randomized into this group, 25 of which are poor responder and the others are normal responders. Participants for placebo comparator are advised to take the drug (placebo) from the time of COH to the date of oocyte retrieval. If pregnancy is not confirmed in the first cycle, all subjects are to enter the second cycle after 1-2 months of recovery period.
For the second cycle, the procedure will be repeated same as the first cycle with doubling of the drug dosage . It should also be administered for 2 weeks until the date of oocyte retrieval.
干预措施: placebo administration (Drug)
结局指标
主要结局
IVF outcome - clinical pregnancy rate
时间窗: at 6-8 weeks of gestation
presence of G-sac in the uterine cavity
IVF outcome - embryo quality
时间窗: 3 to 5 days after oocyte retrieval
grade the embryos\& blastocysts according to the Lucinda Veeck \& Gardner
IVF outcome -biochemical pregnancy rate
时间窗: on day 12~14 after embryo transfer
serum human chorionic gonadotropin level\>10 IU
IVF outcome - oocyte quality
时间窗: 3 days after oocyte retrieval
Evaluate oocyte quality on morphological standard as following category- Mature oocyte, Intermediate oocyte, atretic oocyte, post mature oocyte
次要结局
- acquired oocyte No(20weeks)
- fertilization rate(20weeks)
- Comparing Pittsburgh sleep quality index(20weeks)
- marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF(20weeks)
研究者
Dong Hee Choi
M.D, Ph.D
Bundang CHA Hospital