EUCTR2015-005660-42-ES进行中（未招募）1 期
Randomized, single blind, prospective clinical study to compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in patients with polycystic ovary under a FIV/ICSI cicle.
Institut de Recerca HSCSP0 个研究点目标入组 164 人开始时间: 2016年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Female age between 18 and 38 years (inclusive)
- •2. Women with a BMI under 30 kg / m2
- •3. Diagnosis of PCOS or polycystic ovary syndrome (according to criteria of Rotterdam)
- •4. Women who want pregnancy
- •5. basal basal FSH levels under or equal 10 IU / l
- •6. Infertility justify treatment with FIV / ICSI-ET
- •7. To be included in a protocol with GnRH antagonist
- •8. Presence of both ovaries and uterus able to support embryo implantation and pregnancy
- •9. Absence of pregnancy before starting ovarian stimulation
- •10. Having given written consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 164
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe male factor not allowing an FIV / ICSI with ejaculated sample
- •2. Patients with low ovarian reserve
- •3. important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
- •4. HIV seropositivity
- •5. to have frozen embryos from previous cycles of assisted reproduction
- •6. undiagnosed vaginal haemorrhage
- •7. Poor response in previous cycles of FIV with standard stimulation protocols
- •8. Pregnancy, lactation or contraindication to get pregnant
- •9. Malformations of the sexual organs incompatible with pregnancy
- •10. History of allergy to gonadotrophin preparations or its excipients
- •11. Alcohol, drugs or psychotropic addiction
- •12. Concurrent participation in another study
- •13. Previous history of severe hyperstimulation syndrome
- •14. 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
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