EUCTR2021-000001-25-PL进行中（未招募）1 期
A phase II, randomised, double-blind, parallel-group, placebo-controlled trial to assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI - OXOART 2 (OXO-001 in Assisted Reproductive Technology, phase 2 trial)
Oxolife S.L.0 个研究点目标入组 351 人开始时间: 2021年5月19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
- 351
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. Voluntary written informed consent before initiation of any trial-related procedures, including the agreement to participate in the pregnancy and infant follow-up if becoming pregnant.
- •2. Infertile female subjects indicated for egg donor programme in the context of ART. Infertility is defined as the failure to achieve a clinical pregnancy after:
- •a. at least 12 months of regular unprotected sexual intercourse, if < 35 years of age,
- •b. at least 6 months of regular unprotected sexual intercourse, if = 35 years of age.
- •3. Subjects aged = 18 to = 45 years at screening.
- •4. Body mass index (BMI) = 18.0 and < 30.0 kg/m2.
- •5. Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening (no presence of gynaecological abnormality suspected to affect the ART procedure and outcome). The TVUS should have been performed in the mid of the second part of a menstrual cycle. .
- •6. Planned transfer of a fresh single blastocyst from a donated egg.
- •7. Good quality sperm (fresh or frozen) available from partner or donor. Sperm assessment must not be older than 6 months prior to screening (fresh and frozen sperm).
- •NOTE: The partner’s consent on the review of his medical source data to assess sperm quality and for the potential use of donor sperms, as applicable, is required.
- •8. Planned endometrial preparation (not natural) and luteal support.
- •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 351
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of failed IVF/ICSI cycles with donor oocyte (each embryo transfer counts as a cycle). As an exception subjects with one previous failed cycle with donor oocyte are eligible only if this resulted in a confirmed biochemical pregnancy (positive B-human chorionic gonadotropin (B-hCG) test) during that cycle.
- •2. Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives (e.g. significant uterine anomaly, communicating hydrosalpinx or submucosal/intramural fibroid(s) that deform the uterine cavity, congenital malformations) documented during transvaginal sonography.
- •3. Abnormal haemorrhage of the reproductive tract of undetermined origin.
- •4. Endometrial biopsy or endometrial local injury within one month prior to screening.
- •5. Diagnosis of severe endometriosis (stage III or IV) and/or adenomyosis.
- •6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
- •7. Relevant clinically significant abnormality in the results of safety laboratory tests at screening.
- •8. Systemic disease (e.g. diabetes, epilepsy, severe migraine, hepatic, renal or cardiovascular disease, severe oral corticosteroid-dependent asthma, autoimmune disease, thrombophilia disease) which might interfere with the purpose of the trial.
- •9. Any malignant neoplasm.
- •10. Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of clotting.
- •11. History of uncontrolled hypertension.
- •12. Known hypersensitivity to any component of the IP used in this trial.
- •13. Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg.
- •14. History (within 12 months) of or known current problems with alcohol or substance abuse.
- •15. Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
- •16. Previous treatment with the IP of this trial at any time or participation in another clinical trial within the past 3 months prior to screening.
- •17. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the principal investigator.
- •18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
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