A Comparative Study, Randomized, Blinded, About the Effect of Pre-treatment With GnRH Analogues Versus Placebo in Infertile Patients With Endometriosis Undergoing in Vitro Fertilization Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate by started cycle
研究概览
简要总结
The purpose of this study is to determine whether the administration of an analogue of gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an IVF may improve the response to ovarian stimulation, implantation rate and clinical pregnancy rate in patients with endometriosis/ endometriomas.
详细描述
Endometriosis is defined as the presence of ectopic endometrial tissue which induces a local inflammatory reaction. Usually, this tissue is located at any level in the pelvic region, but extrapelvic locations have been described. It is a chronic disease whose cause is unknown, although a genetic predisposition has been proven. It is estimated that endometriosis affects 7-15% of women of fertile age, and up to 30-40% of women with endometriosis have infertility.
Assisted reproduction techniques (ART) are the treatment of many causes of infertility, including endometriosis. The results of assisted reproduction in women with endometriosis appear to be somewhat worse than those obtained from women without endometriosis. Some authors have proven a significant reduction in implantation and pregnancy rates in these patients.
The worst pregnancy rate and implantation is believed to be originated in a poor oocyte quality, which can lead to a lower rate of fertilization. This poor oocyte quality produce poorer quality embryos with a reduced capacity to implant, particularly in severe endometriosis.
On the other hand, endometrial receptivity does not appear to contribute to the reduction of results of ART in these women.
In an attempt to improve ART outcomes in women with endometriosis, different strategies have been proposed prior to the cycle realization, with different results.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Infertile women with endometriosis diagnosed by surgery in the previous year to their inclusion in the study with signs of residual disease and/or by the existence of ovarian endometrioma in vaginal ecography who are susceptible to IVF treatment.
- •BMI < 28 Kg/m2
- •Age < 40 years old
- •Signed informed consent to perform IVF and participation in this study
排除标准
- •Follicle stimulating hormone (FSH) 2nd-5th cycle day > 12 IU/L
- •Liver disease (sALAT> 80 IU/L)
- •Kidney disease (creatinine > 130 nmol/L)
- •Other relevant disease that contraindicates a pregnancy
研究组 & 干预措施
GnRHa
Triptorelin acetate 3,75 mg subcutaneous injection administered on days 1, 28 and 56 after menstrual cycle.
干预措施: Triptorelin acetate (Drug)
Physiological serum
physiological serum subcutaneous injection with same delivery device and same volume that active comparator ) administered on days 1, 28 and 56 after menstrual cycle.
干预措施: Triptorelin acetate (Drug)
结局指标
主要结局
Clinical pregnancy rate by started cycle
时间窗: 2 weeks after biochemical diagnosis of pregnancy
Number of pregnancies with fetal hearth beat on ultrasound exam divided by total number of started cycle
次要结局
- Total dose of gonadotropins and days of treatment(Day of the administration of human chorionic gonadotropin (hCG))
- Number of oocytes retrieved, total and metaphase II(In the moment of oocyte retrieval)
- Embryo quality(Two-three days after oocyte recovery and IVF)
- Rate of pregnancy to term in patients with endometriosis / endometriomas(37 weeks after cycle)
- Rate of healthy and live births(37th to 41st weeks of pregnancy)
- Fertilization rate(Two days after oocyte recovery and IVF)
- Number and size of endometrioma(s)(Day of the Basal ultrasound)
- Miscarriage rate(22nd week of pregnancy)
- Ovarian Hyperstimulation Syndrome (OHSS) incidence(One month after hCG)
- Cancellation rate and causes(Last day of gonadotropin treatment)