EUCTR2009-017674-20-BE进行中（未招募）不适用
Efficacy, safety and tolerability of XM17 compared to Gonal-f® in women undergoingassisted reproductive technologies.A multi-national, multi-centre, randomised, controlled, assessor-blind, parallel groupPhase III study including follow-up periods
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
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
- •5. Body mass index (BMI) between 18-29 kg/m2 inclusive.
- •6. Transvaginal ultrasound documenting the presence of both
- •ovaries without abnormalities and normal adnexa within the
- •last six 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 six months prior to
- •study entry.
- •10. Negative pregnancy test prior to starting pituitary
- •down-regulation.
- •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.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. More than two previously completed consecutive unsuccessful
- •IVF cycles (i.e. completed cycle = oocyte retrieval).
- •2. Primary ovarian failure or women known as poor responders.
- •3. More than three miscarriages.
- •4. History of a severe ovarian hyperstimulation syndrome
- •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 > 160 mmHg and diastolic blood
- •pressure > 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 radiotherapy.
- •18. Use of concomitant medications that might interfere with study
- •evaluations (e.g. prostaglandin inhibitors, psychotropic
- •19. Known allergy or hypersensitivity to recombinant FSH
- •preparations or one of their excipients.
- •20. History of drug or alcohol abuse (last three years), current or
- •past (three months) smoking habits of >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
研究者
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