EUCTR2004-001307-35-GB进行中（未招募）1 期
A prospective, open label, randomised, parallel group, comparative pilot study to study the efficacy and safety of highly purified Menotrophin versus recombinant FSH (Follitropin alfa) administered subcutaneously to subfertile female patients undergoing IVF using antagonist downregulation. - PROSPECT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •The patients must meet all of the following inclusion criteria
- •Signed informed consent;
- •Subfertile premenopausal female patients eligible for IVF treatment;
- •Aged more than or equal to 20 and less than or equal to 35 years;
- •Body mass index of >18 and <32 kg/m2;
- •Normal endocrine assessment within the last 6 months;
- •Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months;
- •Receipt of no more than two previous cycles of IVF (or other ART);
- •At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months;
- •No fertility-modifying treatment within the 3 months prior to this treatment cycle;
- •Infertility attributable to or in association with either tubal factor, or unexplained causes;
- •Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy;
- •Negative serum beta-HCG pregnancy test prior to beginning therapy;
- •Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests;
- •Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory
- •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
- •The patient may not be entered into the study if any of the following exclusion criteria exist.
- •Presence of any clinically relevant systemic disease (e.g. insulin-dependent diabetes mellitus);
- •A history of or current endocrine disease, including polycystic ovary-like syndrome and hyperprolactinaemia;
- •A history of coagulation disorders;
- •Persistent ovarian cysts;
- •Contraindications for the use of gonadotrophins or GnRH antagonists;
- •A history of hypersensitivity to any of the constituents of the study medication or related compounds;
- •Three or more previous cycles of IVF (or other ART);
- •A history of alcohol abuse (more than 30 units per week on a regular basis);
- •History of chemo- or radiotherapy;
- •Currently breast-feeding, pregnant or with a contraindication to pregnancy;
- •Diagnosed poor responders in prior IVF treatment;
- •History of severe OHSS (4 or 5) in former IVF treatment;
- •Investigational drug within the 30 days prior to treatment;
- •Any other condition or history that the investigator considers might increase the risk to the individual.
研究者
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