Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in the levels of anti-Mullerian hormone
研究概览
简要总结
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).
Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone (AMH). Secondary objectives will be effect on pelvic pain, other symptoms, sexual function, quality of life, progression in size of the endometrioma, impact on work productivity and activity impairment, and satisfaction with treatment.
Participants will be followed by up to one year.
详细描述
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).
Secondary objectives were the comparison of the effect on i) pelvic pain, including dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia, or dyschezia, ii) other symptoms including menorrhagia, gastrointestinal symptoms different to dyschezia, or urinary symptoms; iii) quality of life as assessed by the EHP-30 questionnaire; iv) sexual functions, as assessed the female sexual function index (FSFI); v) progression in the size of the tumor in the case of the two non-surgical approaches; vi) impact on work productivity and activity impairment; vii) satisfaction in the patient.
A prospective assessment will be performed on a cohort of women with endometrioma diagnosed by ultrasound from diagnosis for up to one year. The assignment to each management option will be performed under usual care conditions so that the selected option will result from the shared clinical decision of the clinician with the patient.
The target population will be composed of Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2.
Participants will be controlled at 3 months, 6 months and one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2
排除标准
- •Previous ovarian surgery;
- •Previous pathologies involving the ovary, including other ovarian tumors, polycystic ovaries, or pelvic inflammatory disease;
- •Previous diagnosis of cancer treated with chemotherapy or local radiotherapy;
- •Diseases affecting the endocrine system, diabetes, thyroid, hyperprolactinemia, or the immune system (lupus, Crohn,…);
- •Genesic wish;
- •Endometrioma >7 cm;
- •Unhealthy habits, including smoking, alcohol consumption above social level, or illicit drugs;
- •Insufficient level of autonomy for unrestrictedly signing informed consent;
- •Current or previous use of hormonal contraceptives, Gonadotropin-Releasing Hormone (GnRH) analogues, any drug with a known effect on endometriosis, or any drug under investigation, for what a washing up period of 6 months will be required in all cases.
结局指标
主要结局
Change in the levels of anti-Mullerian hormone
时间窗: Change from baseline AMH levels at 1 year
Ovarian reserve as measured by the levels of AMH
次要结局
- Change of Pelvic pain(Change from baseline pelvic pain at 1 year.)
- Change in quality of life(Change from baseline EHP-30 score at 1 year.)
- Change in sexual function(Change from baseline FSFI score at 1 year.)
- Change in volume of the tumor(Change from baseline endometrioma volume at 1 year.)
- Satisfaction of the patient(Satisfaction level measured by Likert scale at 1 year.)
研究者
Antonio Cano Sanchez
Professor Obstetrics & Gynecology
University of Valencia