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临床试验/NCT01839136
NCT01839136终止不适用

Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
2
主要终点
Live birth

研究概览

简要总结

Background: The cost for the treatment of infertility are limiting for the health care access, particularly if we consider that the success rate per cycle is approximately 35%. Alternative regimens for controlled ovarian stimulation (COS)have been described in the medical literature, that lead to a lower cost, fewer injections and less risk of adverse events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report excellent results with less manipulation as possible, which reduces the cost of laboratory of human and ethically be considered less complicated once fertilization occurs in the uterus and not in vitro.

Objectives: The main objective is to compare the reproductive outcomes between intrauterine transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average number of eggs that are raised when using an EOC reduced cost.

Methods: This study will be conducted in the area of Human Reproduction, Department of Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study with random allocation of the participants in a 1:1 ratio, and we plan to include 100 participants. All participants will undergo an EOC reduced cost. We will compare the chance of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated and to estimate the number of oocytes retrieved considering all participants.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing ART requiring COS, oocyte retrieval and embryo transfer at the fertility clinic of the university Hospital of the Medical School of Ribeirao Preto, University of Sao Paulo, Brazil.
  • Age = 18-40 years
  • BMI = 18-30 Kg/m²
  • Antral follicle count (AFC) ≥ 5
  • Semen concentration and progressive motility above the percentile 2.5 of the fertile men (Cooper et al. 2010): sperm concentration > 9X 10⁶/mL, and progressive motility > 28%.

排除标准

  • 未提供

结局指标

主要结局

Live birth

时间窗: 9 months

次要结局

  • Clinical pregnancy(2 months)
  • Number of oocytes retrieved(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wellington P Martins, MD

Physician and researcher

University of Sao Paulo

研究点 (2)

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