EUCTR2013-003817-16-NL进行中（未招募）不适用
A phase III, randomized, controlled, single-blind,multicentre, parallel arm trial to assess theefficacy and safety of Pergoveris® (follitropin alfaand lutropin alfa) and GONAL-f® (follitropinalfa) for multifollicular development as part of anassisted reproductive technology treatment cyclein poor ovarian responders, as defined by theEuropean Society of Human Reproduction andEmbryology criteria - ESPART Evaluating the Efficacy and the Safety of Pergoveris (r) 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 according as aligned with the 2011 Consensus Meeting of the ESHRE. 1. Subject must be a poor responde
- •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 dates 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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