Randomized, Single Blind, Prospective Clinical Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Quantity of mature oocytes respect to the total oocytes
研究概览
简要总结
Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in isolation, its therapeutic management has special connotations sometimes favoring the low response although the standard is the tendency to hyperresponsiveness.
Although there are studies comparing the combination of FSH and LH and FSH in controlled hyperstimulation of these patients, there are no previous prospective randomized studies comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).
Therefore the aim of this study is to prove that both drugs are comparable in the treatment of these patients. The test substances are marketed in Spain (Fostipur and Meriofert, respectively) with an indication for use in these patients. In this study both medicines will be administered in a randomized way under the usual conditions in which it is used in routine clinical practice to compare the quantity of mature oocytes respect to the total oocytes obtained, as a primary outcome measure.
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
- Single (Investigator)
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
- •Female age between 18 and 38 years (inclusive)
- •Women with a BMI under 30 kg / m2
- •Diagnosis of polycystic ovary syndrome (according to criteria of Rotterdam)
- •Women who want pregnancy
- •Basal basal FSH levels under or equal 10 IU / l
- •Infertility justify treatment with in vitro fertilization / intracytoplasmic sperm injection
- •To be included in a protocol with GnRH antagonist
- •Presence of both ovaries and uterus able to support embryo implantation and pregnancy
- •Absence of pregnancy before starting ovarian stimulation
- •Written consent
排除标准
- •Severe male factor not allowing an in vitro fertilization / intracytoplasmic sperm injection with ejaculated sample
- •Patients with low ovarian reserve
- •Important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
- •HIV seropositivity
- •To have frozen embryos from previous cycles of assisted reproduction
- •Undiagnosed vaginal haemorrhage
- •Poor response in previous cycles of in vitro fertilization with standard stimulation protocols
- •Pregnancy, lactation or contraindication to get pregnant
- •Malformations of the sexual organs incompatible with pregnancy
- •History of allergy to gonadotrophin preparations or its excipients
- •Alcohol, drugs or psychotropic addiction
- •Concurrent participation in another study
- •Previous history of severe hyperstimulation syndrome
- •Concomitant medication that may interfere with the study medication: different hormonal treatments used in the study, other thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with inhibitors of prostaglandin
研究组 & 干预措施
Fostipur
干预措施: hFSH-HP (Drug)
Meriofert
干预措施: hMG-HP (Drug)
结局指标
主要结局
Quantity of mature oocytes respect to the total oocytes
时间窗: 30 days
次要结局
未报告次要终点