NCT01732900已完成不适用
The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.
Gema Diagnostics8 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2013年2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
- 133
- 试验地点
- 8
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.
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
- 21 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 21-39 years
- •IVF cycle 1 or 2
- •Fertilization method: ICSI and/or IVF
- •Day 3 or day 5 embryo transfer
- •Treatment cycle intended for single or double embryo transfer
- •Use own oocytes, not oocyte donor
- •≥ 3 embryos at final assessment
- •Donor sperm acceptable
- •Willing to comply with protocol and study procedures
排除标准
- •Polycystic Ovarian Syndrome
- •Presence of fibroid(s): >4 cm intramural or submucosal fibroids
- •History of chemotherapy or radiation to the abdomen or pelvis
- •Use of donor oocytes
- •Use of reinseminated oocytes
- •Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
- •Concurrent participation in another clinical study
- •(Male): Surgically removed sperm
- •(Male): <5 million sperm count
结局指标
主要结局
Clinical pregnancy rate
时间窗: Recorded at post-transfer week 4-9
Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
Unknown
不适用
Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Tumor Specimens in Breast CancerBreast TumorNCT01247480National University Hospital, Singapore
已完成
不适用
Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary TreeChest PainCardiovascular DiseasesCADCHDCVDCoronary Heart DiseaseCoronary Artery DiseaseAngina PectorisNCT00500617CardioDx4,350
进行中（未招募）
不适用
Gene expression as predictive markers of outcome in non-small cell lung cancer patients (stage IIIB with pleural effusion and stage IV) treated with chemotherapy. Phase II trial of GOIRC. - NDpatients with non-small cell lung cancer cells in stage IIIB (with supraclavicular lymphnode metastases and / or pleural effusion) or IV, not previously treated with chemotherapy for advanced diseaseMedDRA version: 9.1Level: SOCClassification code 10029104EUCTR2009-017094-38-ITGRUPPO ONCOLOGICO ITALIANO DI RICERCA
招募中
不适用
Validation of the Genetic Signature 354849 as a Prognostic MethodCervix CancerNCT04067882National Institute of Cancerología189
招募中
不适用
Evaluation of biomarkers and gene expression profile related to peripheral microvascular reserve in patients with severe infectionssepsisRBR-10jksk74Hospital de Clínicas - Universidade Federal do paraná