EUCTR2013-003817-16-EE进行中（未招募）不适用
A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria - ESPART Evaluating the Efficacy and the Safety of Pergoveris®in ART
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
- Merck KGaA
- 入组人数
- 946
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
- •The current trial will enroll poor ovarian responders as aligned with the 2011 Consensus Meeting of the ESHRE
- •1. Subject must be a poor responder
- •at least 2 of the following 3 features must be present:
- •? ESHRE criteria = Advanced maternal age (= 40 years) or any risk factor for POR - INCLUSION for this study: Yes (< 41 years), no for any risk factor
- •? ESHRE Criteria = A previous POR (= 3 oocytes with a conventional stimulation protocol)
- •INCLUSION for this study: Yes
- •? ESHRE Criteria = An abnormal ovarian reserve test (ORT) (ie, anti-mullerian hormone [AMH] < 0.5 - 1.1 ng mL)
- •INCLUSION for this study: Yes for AMH only (= lower limit of assay detection – 1.3 ng/mL, inclusive)
- •Additional inclusion criteria are:
- •2.Female subjects, 18 to < 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
- •3.Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
- •4.Absence of any medical condition in which pregnancy is contraindicated
- •5.Body mass index 18 to 30 kg/m2, inclusive
- •6.Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial.
- •7.Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
- •8.Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment
- •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 946
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Primary ovarian failure
- •2.Preimplantation genetic screening or diagnosis
- •3.Two episodes of POR after maximal stimulation
- •4.History or presence of tumors of the hypothalamus or pituitary gland
- •5.History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization
- •6.Presence of endometriosis Grade III – IV, confirmed or suspected
- •7.Presence of uni- or bilateral hydrosalpinx
- •8.Abnormal gynecological bleeding of undetermined origin
- •9.Malformations of sexual organs incompatible with pregnancy
- •10.Contraindication to being pregnant and/or carrying a pregnancy to term
- •11.Currently pregnant
研究者
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