Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Occurrence rate of Ovarian hyper stimulation syndrome
研究概览
简要总结
This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.
详细描述
Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation which might be life threatening in the severe forms. Since there is still no definite cure for this syndrome, prevention is considered as an essential and vital issue. The objective of this study is to determine the effect of Methylprednisolone to prevent ovarian hyper stimulation syndrome in IVF cycles.
The study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea, hyper androgynism (clinical or laboratory), LH/FSH>2 and ovarian morphological evidences in Doppler ultrasound.
The existence of more than 20 follicles in both ovaries and E2 concentration >4000 pg/ml will be considered as the OHSS risk factors.
In this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:
Treatment group (case) will be administered 16 mg Methylprednisolone initiated from the first day of stimulation and will be tapered after the first pregnancy test (day 13 after the embryo transfer). Furthermore, these patients will receive a bolus IV dose methylprednisolone, 1g on the day of egg collection and embryo transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Poly Cystic Ovarian Syndrome patients
- •Indication for IVF/ICSI and Long Protocol ovarian stimulation
- •Basal FSH≥10
- •Normal BMI (20-25)
- •physical health
排除标准
- •Allergy to GnRH analogues, FSH and corticosteroids
- •presence of heart failure, recent myocardial infarction
- •Hypertension
- •Diabetes mellitus
- •hypothyroidism
- •hepatic failure
- •osteoporosis
- •peptic ulceration
- •renal impairment
- •Using drugs that have interaction with corticosteroids such
研究组 & 干预措施
Case
Administration of Methylprednisolone
干预措施: Methylprednisolone (Drug)
Control
干预措施: Control (Drug)
结局指标
主要结局
Occurrence rate of Ovarian hyper stimulation syndrome
时间窗: Until 20 days after embryos transfer
次要结局
- Estradiol concentration in the day before hCG administration(Until 20 days after embryos transfer)
- Retrieved and injected oocytes number and quality(Until 20 days after embryos transfer)
- Achieved and transferred embryos number and quality(Until 20 days after embryos transfer)
- Implantation rate(Until 20 days after embryos transfer)
- Chemical and clinical pregnancy rate and cancelation rate(Until 20 days after embryos transfer)