EUCTR2017-004298-15-ES进行中（未招募）1 期
A Phase III multicentre, randomized, unblinded clinical trial to test the effect of treatment with recombinant LH prior to controlled ovarian stimulation in poor ovarian responder women with an advanced maternal age
IVI Alicante0 个研究点目标入组 88 人开始时间: 2018年8月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
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.- The current trial will include patients with POR according to specific criteria that are in line with the criteria defined by the ESHRE (Bologna Criteria), according to which a patient is classified as a poor ovarian responder when she meets two of the three of the following criteria:
- •I.- Previous episode of POR (> or = 3 oocytes) with conventional stimulation protocol.
- •II.- Abnormal ovarian reserve test with an antral follicle count (AFC) <5-7 and/or anti-mullerian
- •hormone values (AMH) <0.5-1.1 ng/mL.
- •III.- Women > or = 40 years old* and/or who have any other risk factor for POR.
- •In addition, two episodes of POR after maximal stimulation are sufficient to define a patient as poor
- •responder in the absence of advanced maternal age or abnormal ovarian reserve test.
- •2. Women > or = 35 to < or = 43 years for COS and assisted reproduction techniques (ART).
- •3.- Couple or single woman, accepting preimplantation genetic diagnosis (PGS) after blastocyst biopsy
- •and delayed transfer for selection of euploid embryos.
- •4.- Body Mass Index (BMI) between18 and 30 kg/m 2 , inclusive.
- •5.- Ejaculatory sperm with concentration > or = 5 mill spermatozoa/mL and > or = 5 mill total spermatozoa progressive motility. Bank and cryopreserved semen allowed.
- •6.- Informed consent completed, signed and dated.
- •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 88
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.- Cases of recurrent spontaneous miscarriage (=2 clinical miscarriages) or implantation failure (after
- •transfer of 6 good D3 embryos or 4 good blastocysts) will be excluded
- •2.- Use of testicular or epididymal spermatozoa as well as ejaculate with concentration < 5 mill
- •spermatozoa/mL and < 5 mill total spermatozoa progressive motility
- •3.- Primary ovarian failure, PCOS (in accordance with the Rotterdam criteria) or ovary/s inaccessible
- •for oocyte retrieval.
- •4.– Anatomical uterine abnormalities and any endometrium or myometrium pathology (adenomyosis,
- •polyps, myoma, etc.) that may interfere with implantation or pregnancy. Patients with previous
- •polypectomy, myomectomy or surgery for septate/subseptate/arcuatus uterus should not be
- •5.- Presence of unilateral or bilateral hydrosalpinx that has not been surgically removed or ligated.
- •6.- Presence of level III-IV endometriosis.
- •7.- History of tumours in the hypothalamus or pituitary gland, or ovarian, uterine or breast cancer.
- •8.- Abnormal bleeding of undetermined origin.
- •9.- Known infection with human immunodeficiency virus, active hepatitis B or C virus in the woman or
- •her partner.
- •10.- Known allergy or hypersensitivity to the drugs administered during the trial.
- •11.- Concurrent significant medical pathologies that would endanger the patient's safety
- •(uncontrolled thyroid or adrenal dysfunction, severe hepatic or renal impairment, etc.) or interfere
- •with the test evaluations or the clinical outcomes (i.e. confirmed thrombophilia).
- •12.- Use of concomitant medication or any other circumstances that, in the opinion of the
- •investigator, interferes with the development of the trial or does not ensure the safety and efficacy of
- •13.- Simultaneous participation in another clinical trial or previous participation in this study.
- •14.- Participation in another clinical study two months before inclusion in the present study that could affect its objectives
研究者
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