Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment
研究概览
简要总结
This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy
详细描述
This is a prospective randomized open-label trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups.
Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Women with infertility / primary infertility.
- •Women who are about to start an IVF/ICSI cycle with their own eggs.
- •Age greater than or equal to 18 years and less than or equal to 40 years.
- •Women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria.
- •Women with uterine ultrasound without endometrial pathology
排除标准
- •Ovarian reserve: Antimullerian hormone <0.5 ng / dl or Count of antral follicles <5 between both ovaries.
- •Myomatous uterus: presence of> 2 myomas> 4cm or that deform uterine cavity.
- •Uterine malformations.
- •Body mass index (BMI) <18 or>
- •Polycystic ovarian syndrome: according to European Society of Human Reproduction and Embryology (ESRHE)/Rotterdam 2003 criteria.
- •Moderate-severe endometriosis.
- •Background or presence of pelvic inflammatory disease.
- •Hydrosalpinx not excised or occluded.
- •Hyperprolactinemia, defined as prolactin levels greater than 50 ng / ml.
- •Diagnostic history of endometrial hyperplasia.
- •Severe male factor: severe oligoasthenoteratozoospermia with a sperm cell count (REM) <100,000 spermatozoa / ml.
- •Impossibility to apply the treatments provided by the study in the terms established by the protocol.
- •Contraindication for the use of any of the treatments provided in the study.
结局指标
主要结局
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment
时间窗: 12 months
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.
次要结局
- Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies.(12 months)
- Rate of hysteroscopy tolerance(1 month.)
- Hysteroscopy complication rate.(2 months)