The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Delta VAS pain
研究概览
简要总结
The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction in patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time intercourses or COS/IUI cycles.
详细描述
Patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time intercourses or COS/IUI cycles will be subjected to subcutaneous or vaginal progesterone for their luteal phase supplementation in time intercourses or IUI cycles.
The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction
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
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Laparoscopic or ultrasonographic diagnosis of endometriosis grade I-II and / or endometrioma <4 cm;
- •Menstrual VAS score> 5 cm before the last menstrual period with progesterone treatment
- •Infertility for at least 1 year
- •Body Mass Index 19 to 30 kg / m2
- •Basal FSH serum <15 IU / ml
- •Normal levels of serum prolactin
- •Normal uterine cavity and fallopian patency
排除标准
- •Previous ovarian surgery
- •Endocrine disorders (eg polycystic ovary syndrome, thyroid disease, hyperprolactinemia, hypogonadotropic hypogonadism)
- •Reduced ovarian reserve (basal levels of FSH> 15 IU / mL)
- •Acute or chronic infectious state
- •Chronic drug intake, alcohol, or drugs that affect cognitive functions, alertness and / or mood
- •Psychiatric disorders
- •Kidney or liver diseases
- •Male factor infertility
研究组 & 干预措施
Pleyris
Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days
干预措施: Pleyris (Drug)
Crinone8
Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days
干预措施: Crinone8 (Drug)
结局指标
主要结局
Delta VAS pain
时间窗: 7 days after the end of the menstrual period subsequent to the luteal supplementation
Patients will be asked to score their menstrual pain using a VAS scale
次要结局
- Analgesic use(7 days after the end of the menstrual period subsequent to the luteal supplementation)
- Pregnancy rate(30 days after the end of the menstrual period subsequent to the luteal supplementation)
研究者
Fulvio Zullo
Full Professor
University Magna Graecia