EUCTR2016-004266-25-DE进行中（未招募）1 期
A phase 3, double-blind, randomized, placebo-controlled study to assess the safety and efficacy of a single oral administration of nolasiban to improve pregnancy rates following IVF or ICSI in Day 3 and Day 5 fresh embryo transfer cycles
ObsEva S.A.0 个研究点目标入组 760 人开始时间: 2016年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 760
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
入选标准
- •1. The Subject must provide written informed consent prior to initiation of any study related procedures, as shown by a signature on the informed consent form.
- •2. The Subject must be aged 18 years to 36 years inclusive at screening.
- •3. The Subject must be indicated for IVF/ICSI in the context of assisted reproductive technology (ART).
- •4. The Subject must have undergone not more than one unsuccesful (negative ßhCG test) COH for IVF or ICSI (whether fresh and/or several frozen ET resulted from that COH). Any attempts before a prior clinical pregnancy (observed embryo with heart beat) do not count.
- •5. The Subject must in the current COH cycle for IVF/ICSI follow a GnRH antagonist protocol with or without pre-treatment with an oral contraceptive pill or estradiol.
- •6. The Subject must in the current COH cycle for IVF/ICSI receive a single injection of hCG for triggering final follicular maturation.
- •7. The Subject must in the current COH cycle for IVF/ICSI receive a luteal phase support with vaginal micronized progesterone at 600 mg per day (or local alternative if not available) beginning the morning after OPU.
- •8. The Subject must undergo oocyte retrieval for IVF/ICSI and subsequent fresh transfer on day 3 or day 5 post-OPU day.
- •9. The Subject must have at least one good quality embryo in the current COH cycle.
- •10. The Subject is scheduled for a single fresh embryo transfer in the current COH cycle.
- •11. The Subject must have at least 1 functional ovary.
- •12. The Subject must have a BMI = 18 kg/m2 and = 38 kg/m2.
- •13. The Subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
- •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 760
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The Subject undergoes a frozen-thawed embryo transfer in the current COH cycle.
- •2. The Subject’s partner required surgical testicular sperm extraction.
- •3. The Subject or partner has a known abnormal karyotype or the subject has known acquired or congenital thrombophilia disease.
- •4. The Subject has any condition, including findings in the medical history or in the pre-trial assessments, which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation.
- •5. The Subject has any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re-test is allowed.
- •6. The Subject has a serum P4 level greater than 1.5 ng/mL on the day of hCG administration.
- •7. The Subject had more than 20 oocytes retrieved in the current COH cycle.
- •8. The Subject has any significant abnormality relevant to the ART procedure and outcome, in the results of the screening gynecological examination, which in the opinion of the PI could interfere with the trial objectives, conduct or evaluation (e.g. significant uterine anomaly, hydrosalpinx or fibroid(s) documented during screening ultrasound).
- •9. The Subject has a known severe endometriosis (stage III or IV) and/or adenomyosis.
- •10. The Subject is at significant risk of severe Ovarian Hyper Stimulation Syndrome (OHSS).
- •11. The Subject has any clinically significant abnormality on arterial blood pressure (BP) or heart rate (HR) at screening.
- •12. The Subject has known positive results from virology tests for hepatitis B surface antigen (HBsAg) (not due to vaccination), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2. However, subjects who have resolved hepatitis B infection may be enrolled in the study.
- •13. The Subject is prone to frequent, severe hypersensitivity to drugs.
- •14. The Subject has been administered with any experimental drug in the 12 weeks before dosing.
- •15. The Subject is likely to require treatment with drugs that are not permitted during the study from the day after OPU up to the the Week 2 visit (OPU day + 14 days) such as:
- •Drugs with utero-relaxant properties: Ca channel blockers, beta-sympathomimetic agents, nitroglycerine, magnesium sulfate (MgSO4), potassium channel openers, NSAIDs, drugs for functional GI disorders
- •Drugs with utero-tonic properties: Dopamine, progesterone antagonists, prostaglandin analogues
- •Triptans and ergotamines
- •16. The Subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse.
- •17. The subject has a history of recurrent pregnancy loss defined as 3 or more consective pregnancy losses including biochemical pregnancies. Miscarriage prior to a live birth does not count.
- •18. The subject has a history of difficult transfers (e.g. tenaculum use or blood stained cathether).
- •19. The subject undergoes a D3 transfer after the randomization limit for D3 t
研究者
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