跳至主要内容
临床试验/NCT01267604
NCT01267604撤回4 期

Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

AGUNCO Obstetrics and Gynecology Centre2 个研究点 分布在 1 个国家开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
2
主要终点
Live birth rate

研究概览

简要总结

An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.

Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).

To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.

As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female age 18-39 years
  • BMI 18-30 kg/m2,
  • Fewer than 3 prior oocyte retrievals,
  • No fertility Problems

排除标准

  • 未提供

研究组 & 干预措施

Recombinant FSH

Active Comparator

225IU rFSH

干预措施: Recombinant FSH (rFSH) (Drug)

Recombinant FSH Inositol Melatonin

Experimental

225IU rFSH, 4g Inositol and 3mg Melatonin

干预措施: rFSH + Inositol + Melatonin (Dietary Supplement)

结局指标

主要结局

Live birth rate

时间窗: 10 months after embryo transfer

Total oocyte number

时间窗: 2 weeks after pharmacological treatment

Number of clinical pregnancies

时间窗: 6 weeks after embryo transfer

次要结局

未报告次要终点

研究者

发起方
AGUNCO Obstetrics and Gynecology Centre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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