EUCTR2018-002910-11-HU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 increase ongoing pregnancy rate following fresh single blastocyst transfer resulting from IVF - IMPLANT 4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ObsEva SA
- 入组人数
- 820
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 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 37 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 (no good quality embryos produced or negative ßhCG test) controlled ovarian hyperstimulation (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. If the subject had one unsuccessful COH cycle, as described in inclusion criteria 4 above, they must have obtained at least one good quality embryo for transfer.
- •6. 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.
- •7. The subject must in the current COH cycle for IVF/ICSI receive a single injection of hCG for triggering final follicular maturation.
- •8. 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 beginning the morning after OPU.
- •9. The subject must undergo oocyte retrieval for IVF/ICSI and subsequent fresh transfer on day 5 post-OPU day.
- •10. The subject must have at least one good quality embryo in the current COH cycle.
- •11. The subject is scheduled for a single fresh embryo transfer in the current COH cycle.
- •12. The subject must have at least 1 functional ovary.
- •13. The subject must have a BMI = 18 kg/m2 and = 38 kg/m2.
- •14. The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
- •15. The subject must agree to participate in the infant follow-up if she becomes pregnant.
- •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 820
- •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 transfer.
- •2. The subject undergoes ET of an embryo from a donor egg in the current transfer.
- •3. The subject’s partner required surgical testicular sperm extraction in that cycle.
- •4. Use of assisted hatching and/or use of adherence compounds (e.g. EmbryoGlue®) for the embryo
- •to be transferred in the study.
- •5. The subject or partner has a known abnormal karyotype or the subject has known acquired or congenital thrombophilia disease.
- •6. Any preimplantation genetic testing of the transferred embryo.
- •7. The subject has any condition, including findings in the medical history or in the pre-trial assessments, which in the opinion of the investigator 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.
- •8. 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.
- •9. The subject has a serum P4 level greater than 1.54 ng/mL prior to hCG administration.
- •10. The subject had more than 20 oocytes retrieved in the current Controlled Ovarian Hyperstimulation (COH) cycle.
- •11. Subject is known to have i) impaired ovarian reserve or ii) biomarker predictor of poor response e.g. FSH, AMH, AFC.
- •12. The subject has any significant abnormality relevant to the ART procedure and outcome, in the
- •results of a gynecological examination within 6 months of screening, which in the opinion of the investigator could interfere with the trial objectives, conduct or evaluation (e.g. significant
- •uterine anomaly, communicating hydrosalpinx or fibroid(s) documented during ultrasound).
- •13. The subject has diagnosed severe endometriosis (stage III or IV) and/or adenomyosis.
- •14. The subject is at significant risk of severe ovarian hyper stimulation syndrome (OHSS).
- •15. The subject has any history of uncontrolled hypertension and/or heart disease.
- •16. 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.
- •17. The subject is prone to frequent, severe hypersensitivity to drugs.
- •18. The subject has been administered any experimental drug in the 12 weeks before dosing.
- •19. The subject is likely to require treatment with drugs that are not permitted during the study from day 4 after OPU up to the Week 2 visit (OPU day + 14 days) such as:
- •Drugs with utero-relaxant properties: calcium channel blockers, beta-sympathomimetic agents,
- •nitroglycerine, parenteral magnesium sulfate (MgSO4), potassium channel openers, NSAIDs.
- •20. The subject has autoimmune disease (e.g. lupus, rheumatoid arthritis) that is being medically treated.
- •21. The subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse.
- •22. The subject has a history of recurrent pregnancy loss defined as 3 or more consecutive pregnancy losses including biochemical pregnancies. Miscarriage prior to a subsequent live birth does not count.
- •23. The subject has a history of difficult transfers (e.g. tenaculum use or blood stained catheter).
研究者
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