ISRCTN74772901已完成3 期
Efficacy, safety and tolerability of XM17 compared to Gonal-f® in women undergoing assisted reproductive technologies: a multinational, multicentre, randomised, controlled, assessor-blind, parallel group phase III study including follow-up periods
BioGeneriX AG (Germany)0 个研究点目标入组 280 人开始时间: 2010年5月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Infertile female patients of any racial origin undergoing superovulation for ART
- •2. Aged 18 - 37 years (inclusive) at the time of enrolment
- •3. Good physical and mental health
- •4. Regular menstrual cycles of 21 - 35 days and presumed to be ovulatory
- •5. Body mass index (BMI) between 18 - 29 kg/m^2 inclusive
- •6. Transvaginal ultrasound documenting the presence of both ovaries without abnormalities and normal adnexa within the last 6 months
- •7. Basal follicle stimulating hormone (FSH), estradiol, prolactin, thyroid stimulating hormone (TSH) within the normal reference ranges at enrolment
- •8. Normal or clinically insignificant haematology, clinical chemistry and urinalysis parameters
- •9. Negative cervical Pap test within the last 6 months prior to study entry
- •10. Negative pregnancy test prior to starting pituitary downregulation
- •11. Able to understand and follow instructions and able to participate in the study for the entire period
- •12. Signed and dated written informed consent
排除标准
- •1. More than two previously completed consecutive unsuccessful in-vitro fertilisation (IVF) cycles
- •2. Primary ovarian failure or women known as poor responders
- •3. More than three miscarriages
- •4. History of a severe ovarian hyperstimulation syndrome (OHSS)
- •5. Malformations of sexual organs incompatible with pregnancy
- •6. One or both ovaries inaccessible for oocyte retrieval
- •7. Ovarian enlargement or cyst of more than 2 cm
- •8. Hydrosalpinx that has not been surgically removed or ligated
- •9. Patient affected by pathologies associated with any contraindication of being pregnant
- •10. Gynaecological haemorrhages of unknown aetiology
- •11. Uncontrolled moderate arterial hypertension defined as systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 100 mmHg
- •12. Any significant cardiovascular, pulmonary, neurologic, allergic, endocrine, hepatic, renal or systemic disease
- •13. Patient with insulin-dependent diabetes mellitus
- •14. History of coagulation disorders
- •15. Known positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B or hepatitis C
- •16. Neoplasm (e.g. tumours of the ovary, breast, uterus, hypothalamus or pituitary gland)
- •17. History of chemo- or radio-therapy
- •18. Use of concomitant medications that might interfere with study evaluations (e.g., prostaglandin inhibitors, psychotropic agents)
- •19. Known allergy or hypersensitivity to recombinant FSH preparations or one of their excipients
- •20. History of drug or alcohol abuse (last 3 years), current or past (3 months) smoking habits of greater than 10 cigarettes per day
- •21. Pregnancy or lactation at enrolment
- •22. Administration of clomiphene or gonadotropins within 30 days prior to enrolment
- •23. Administration of investigational drugs within 90 days prior to enrolment
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