EUCTR2006-004684-58-CZ进行中（未招募）不适用
A randomised, assessor-blind, parallel groups, multi-centre, exploratory study assessing the impact of subcutaneous administration of degarelix 2.5 mg on synchronisation of follicle cohort compared to placebo and evaluating the effects of degarelix 2.5 mg started in the mid-luteal or early follicular phase on endometrial receptivity compared to a fixed gonadotrophin releasing hormone antagonist protocol in oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies - EASYFIX Exploratory Study Assessing Synchronisation of Follicles with Degarelix
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
- 80
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.Signed Informed Consent Form, prior to screening evaluations
- •2.In good physical and mental health
- •3.Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation
- •4.Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory
- •5.Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
- •6.Transvaginal ultrasound documenting presence and adequate visualization of the uterus without obvious structural abnormalities which could compromise endometrial biopsy sampling (results obtained within 12 months prior to randomisation)
- •7.Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of abnormality (e.g., no endometrioma of 3 cm or greater), and normal adnexa (e.g., no hydrosalpinx) (results obtained within 6 months prior to randomisation)
- •8.Early follicular phase serum levels of FSH within normal limits (1-12 IU/L) (results obtained within 12 months prior to randomisation)
- •9.Early follicular phase antral follicle (2-10 mm) count = 10 on cycle day 3 (±1 d) of the screening cycle
- •10.Willing to donate the retrieved oocytes
- •11.Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit
- •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.Abnormal karyotype
- •2.Any known clinically significant systemic disease (e.g., insulin dependent diabetes)
- •3.Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
- •4.Diagnosed with polycystic ovarian syndrome or endometriosis stage III / IV
- •5.Diagnosed as poor responder”, defined as
- •a)> 20 days of gonadotrophin stimulation in a previous COH cycle, or
- •b)Any previous cancellation of a COH cycle due to limited follicular response, or
- •c)Development of less than 4 follicles = 15 mm in a previous COH cycle
- •6.History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy)
- •7.Severe OHSS in a previous COH cycle
- •8.Undiagnosed vaginal bleeding
- •9.Pregnancy or lactation
- •10.Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
- •11.Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), anti-psychotics (ATC code N05A), anti-depressants (ATC code N06), anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of prostaglandin inhibitors (non-steroid anti-inflammatory drugs (NSAIDs), including aspirin) within 2 weeks prior to randomisation
- •12.Current or past (12 months prior to randomisation) abuse of alcohol or drugs, and/or current (last month) use of alcohol (more than 14 units per week)
- •13.Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day
- •14.History of chemotherapy (except for gestational conditions) or radiotherapy
- •15.Use of any investigational drug during 3 months prior to start of the current COH cycle
- •16.Previous participation in the study
- •17.Hypersensitivity to any trial product
研究者
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