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临床试验/NCT01886118
NCT01886118已完成不适用

A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility

Clinique Ovo1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
1
主要终点
Pregnancy rates

研究概览

简要总结

One of the main factors in the success of in-vitro fertilization is the quality of the environment of the embryo. In contrast to maternal age, the environment in which the embryo develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting culture media have been attempted in order to reproduce as much as possible the natural, physiological environment of the mother for the embryo in in-vitro fertilization. However, the different new culture media used are devoid of growth factors normally secreted by uterine cells that enhance the interaction between the embryo and its environment.

Because the endometrial lining of the uterus secretes many different cytokines necessary for growth of the embryo, a new procedure has been developed to mimic the natural environment of the growing embryo using autologous (patient's own) endometrial cells in co-culture with the embryo. Endocell, a product developed by Genévrier Laboratories, received commercial authorization in France in 2011. It is the only system of autologous embryo-endometrium co-culture available on the actual market. The process consists of developing the embryo on a monolayer of the patient's own endometrial cells in order to favor its growth until the blastocyst stage (day 5) and to improve its implantation.

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, Care Provider)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Undergoing In Vitro Fertilization (IVF) or IVF/Intra Cytoplasmic Sperm Injection (ICSI) at OVO clinic
  • •Having a prescription of a long, short or an antagonist IVF protocols using both urinary and synthetic gonadotropins
  • •Having a single embryo transfer
  • •Regular menstrual cycles
  • •Basal follicle stimulating hormone levels less than 10 IU/l within 6 months prior to entering the study
  • •anti-mullerian hormone more than 1 ng/ml measured within a year
  • •Normal sonohysterogram or hysteroscopy done within the last 2 years
  • •Previously undergone a maximum of 3 IVF cycles
  • •Documented negative serology tests within 1 year prior recruitment for: Hepatitis B, Syphilis, HIV based on Health Canada recommendations for treatment in an IVF laboratory.

排除标准

  • •Amenorrhea
  • •Anovulatory cycles
  • •Polycystic Ovarian syndrome
  • •Chronic endometritis
  • •Severe endometriosis
  • •Hydrosalpinx
  • •Uterine synechia or Asherman's syndrome
  • •Submucosal uterine fibroids or intra-cavitary polyps greater than 1cm
  • •Uterine anomalies
  • •Use of anticoagulants
  • •Secretory Azoospermia

研究组 & 干预措施

Autologous Endometrial Co-Culture

Experimental

The embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5.

干预措施: Endometrial biopsy (Procedure)

Autologous Endometrial Co-Culture

Experimental

The embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5.

干预措施: Autologous Endometrial Co-Culture (Other)

Conventional media culture

Active Comparator

Patients in this arm will have their embryos cultured in conventional media

干预措施: Endometrial biopsy (Procedure)

Conventional media culture

Active Comparator

Patients in this arm will have their embryos cultured in conventional media

干预措施: Conventional media culture (Other)

结局指标

主要结局

Pregnancy rates

时间窗: 7 weeks

Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound

次要结局

  • Embryo quality(5 days)
  • Blastulation rate(5 days)
  • Cumulative pregnancy rate with frozen embryos(5 years)

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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