Timing of Development in Embryos Derived From Women With Polycystic Ovairan Syndrome and Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Embryonic developmental timing assessed by Time-lapse analysis
研究概览
简要总结
Polycystic ovary syndrome is one of the most common causes of female infertility. The cause of infertility in PCOS is unknown. Factors other than anovulation, including inherited or induced changes in the embryo quality have been suggested. Time-lapse analysis of embryo development is a sensitive method of detecting reduced embryo viability. Yet, there are no data regarding the embryo development in PCOS assessed by time-lapse analysis.
详细描述
Method A consecutive cohort of 249 infertile women attending In vitro fertilization (IVF) or Intra-cytoplasmic sperm injection (ICSI) treatment at the Fertility Clinic, Arhus University Hospital was requited from February 2011 to May 2013. During the period, couples undergoing IVF/ICSI treatment were offered blastocyst culture to day 6 and time-lapse imaging (TLI) as part of a study evaluating parameters for embryo selection (Kirkegaard et al. 2013). Women aged < 38 years without endometriosis and with more than > 8 oocytes retrieved were eligible. Patients were categorized in two groups. Women with regular menstrual cycles and no clinical signs of PCOS (non-PCOS) and women fulfilling the Rotterdam diagnostic criteria for PCOS detected by the presence of anovulation and polycystic ovaries PCO, which was diagnosed by luteal-phase progesterone testing and trans-vaginal ultrasound, respectively. Biochemical parameters of androgen excess were included in the diagnosis when available, , whereas subjective symptoms of androgen excess (acne, hirsutism, alopecia) were not included.
Ethical approval Written informed consent was obtained from all patients before inclusion. The Central Denmark Region Committees on Biomedical Research Ethics and the Danish Data Protection Agency approved the study.
Ovarian stimulation:
Patients were treated with individual doses of gonadotropin, based on serum AMH and/or antral follicle count. Patients were stimulated by either a GnRH agonist- or antagonist protocol using rec-FSH or HMG for stimulation according to clinical guidelines. A dose of 10,000 IU of hCG was administered when at least 3 follicles measured ≥ 17 mm, and UL guided oocyte retrieval was conducted 36 h later.
Oocyte retrieval and ICSI/IVF Ovarian stimulation and oocyte retrieval were performed according to standard procedures. After fertilization, ICSI embryos were immediately placed in the time-lapse incubator (EmbryoScope™). IVF embryos were cultured for approximately 18 h in a conventional incubator. Before IVF embryos were transferred to the EmbryoScope, adhering cumulus cells were removed to ensure optimal image acquisition. In the EmbryoScope, all embryos were cultured until arrest or removal at day 6.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged < 38 years without endometriosis and with more than > 8 oocytes retrieved were eligible. -
排除标准
- •All embryos with more or less than 2 pronuclei, and that did not undergo first cleavage were excluded
结局指标
主要结局
Embryonic developmental timing assessed by Time-lapse analysis
时间窗: From fertilization until transfer at day 6
Embryos were cultured in a time-lapse incubator until arrest or removal at day 6. The time-point of an event was annotated and analyzed for the embryos in focus (in order of appearance).The influence of PCOS on embryo developmental timing was tested in regression models for patient-clustered data
次要结局
未报告次要终点
研究者
Helene Nørrelund
Consultant
University of Aarhus