Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
It is generally assumed that the major causes of in vitro fertilization (IVF) failure in women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and low quality of embryos. The use of prolonged courses of hormone therapy may play an important role in the strategy of overcoming endometriosis-related infertility. The aim of this study was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis undergone a previous IVF failed cycle
详细描述
The primary outcomes of the study are clinical pregnancy rate and live birth rate after reaching 24 week's gestation.
Secondary outcomes of the study are: changes in the diameter and volume of the largest endometrioma, total gonadotropin dose administered, number of mature oocytes collected, number of two-pronuclear (2PN) embryos, number of blastocysts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of endometriosis at magnetic resonance imaging or transvaginal ultrasonography;
- •one failed previous IVF cycle (including failure of frozen embryo transfer);
- •basal FSH < 14.0 IU/L;
- •antimullerian hormone (AMH) blood level >= 0.5 g/mL;
- •normal thyroid-stimulating hormone and prolactin.
排除标准
- •history of surgery for endometriosis;
- •history of uterine or adnexal surgery;
- •use of hormonal therapies for the treatment of endometriosis related pain within 6 months before IVF;
- •adenomyosis (magnetic resonance imaging or transvaginal ultrasonography);
- •hydrosalpinx;
- •submucosal fibroids;
- •body mass index (BMI) ≥ 30 kg/m2;
- •severe male factor infertility (< 5 million total motile sperm count).
研究组 & 干预措施
Patients pretreated with DNG
Patients having received a three-month treatment with DNG before undergoing IVF
干预措施: Dienogest 2 MG (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 8 weeks
Live birth rate after reaching 24 week's gestation
时间窗: 24 weeks
次要结局
- Number of blastocysts.(During the procedure)
- Total gonadotropin dose administered(During the procedure)
- Number of two-pronuclear (2PN) embryos(During the procedure)
- Number of mature oocytes collected(During the procedure)
研究者
Fabio Barra
Principal Investigator
Ospedale Policlinico San Martino