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临床试验/NCT01909570
NCT01909570已完成不适用

Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer

University Hospital Virgen de las Nieves2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
194
试验地点
2
主要终点
Clinical Pregnancy Rate

研究概览

简要总结

The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate

详细描述

The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.

This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women less tan 38 years
  • women Body Mass Index (BMI) between 19-39 kg/m2
  • Follicle-Stimulating Hormone (FSH) <15 mUI/mL on cycle third day
  • First IVF/ICSI cycle or second after a positive pregnancy test in the first one

排除标准

  • More tan five years of infertility
  • Previous uterus surgery
  • Uterus malformations
  • More tan one miscarriage

结局指标

主要结局

Clinical Pregnancy Rate

时间窗: Seven weeks after embryo transfer

A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy

次要结局

  • Multiple Pregnancy Rate(Seven weeks after embryo transfer)

研究者

发起方
University Hospital Virgen de las Nieves
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Clavero Gilabert

PhD MD

University Hospital Virgen de las Nieves

研究点 (2)

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