EUCTR2010-023534-23-DK进行中（未招募）不适用
A phase IIIB, multicentre, multinational, randomized, open-label trial to compare the efficacy and safety of ovarian stimulation with GONAL-f day 1 to day 5 followed by Pergoveris starting day 6 to Pergoveris starting day 1 in women between 36 and 40 years of age undergoing assisted reproductive technique (ART) - PERSIST study (PERgoveriS In Stratified Treatment) for ART
Merck Serono S.A. - Geneva0 个研究点目标入组 208 人开始时间: 2011年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
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
- •-Female subject justifying an IVF/ET treatment
- •-Between her 36th and 40th birthday (both included) at the time of the randomisation visit
- •-Early follicular phase (day 2-4) serum level of basal FSH -Body mass index (BMI) < 30 kg/m2
- •-Regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- •-Presence of both ovaries
- •-Normal uterine cavity, which in the Investigator's opinion is comparable with pregnancy
- •-Negative cervical PAP test within the last 6 months prior to randomisation
- •-At least one wash-out cycle (defined as 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy
- •-Willing and able to comply with the protocol for the duration of the trial
- •-Having given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that the consent may be withdrawn by the subject at any time without prejudice to her future medical care
- •-Having a male partner with semen analysis within the last 6 months prior to randomisation considered adequate to proceed with regular insemination or ICSI according to the centre's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
- •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 208
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-Had >/= 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as /= 25 oocytes retrieved
- •-Had >/= 3 previous ART cycles
- •-Any medical condition, which in the judgement of the Investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical Responsible
- •-Previous severe OHSS
- •-Patients with primary ovarian failure
- •-Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- •-Presence of endometriosis requiring treatment
- •-Uterine myoma requiring treatment
- •-Any contraindication to being pregnant and/or carrying a pregnancy to term
- •-Extra-uterine pregnancy within the last 3 months prior to screening
- •-History of 3 or more miscarriages (early or late miscarriages) due to any cause
- •-Tumors of the hypothalamus and pituitary gland
- •-History of presence of ovarian enlargement or cyst of unknown aetiology
- •-Ovarian, uterine or mammary cancer
- •-A clinically significant systemic disease
- •-Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
- •-Abnormal gynaecological bleeding of undetermined origin
- •-Known allergy or hypersensitivity to human gonadotrophin preparations
- •-Smoking >/= 10 cigarettes per day
- •-Any active substance abuse or history of drug, medication or alcohol abuse in the last 5 years prior to the screening visit
- •-Entered previously into this trial or simultaneous participation in another clinical trial
- •-Pregnancy and lactation period
- •-Participation in another clinical trial within the past 30 days
研究者
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