Phase II, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial to Assess Ongoing Pregnancy Rate With OXO-001 (200/300 mg) or Placebo at 10 Weeks Following Fresh Single Blastocyst Transfer From Donor Oocyte IVF/ICSI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 28
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The main objective of this clinical research trial is to test the efficacy of OXO-001 in a daily oral administration increasing the pregnancy rate in IVF/ICSI by preparing the uterus to receive the embryo.
详细描述
Assisted reproductive techniques are the most common procedures to fulfill the desire for pregnancy in infertile women. Unfortunately, more than half of the assisted reproduction cycles result in implantation failure or early pregnancy loss, the two main causes of infertility and the most important unmet medical need in the field of infertility with current treatments.
This clinical trial aims to test the capacity of OXO-001 to enhance embryo implantation. It is a phase II, randomised, double-blind, parallel-group, placebo-controlled trial that will 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntary informed consent.
- •Infertile female subjects indicated for egg donor programme in the context of ART.
- •Subjects aged ≥ 18 to ≤ 45 years at screening.
- •Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m
- •Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening.
- •Planned transfer of a fresh single blastocyst from a donated egg.
- •Good quality sperm.
- •Planned endometrial preparation and luteal support.
排除标准
- •History of two or more failed in-vitro fertilisation (IVF) / intra-cytoplasmic sperm injection (ICSI) cycles after embryo transfer of donor oocyte during the last attempts prior to the trial.
- •Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives.
- •Abnormal haemorrhage of the reproductive tract of undetermined origin.
- •Endometrial biopsy or endometrial local injury within one month prior to screening.
- •Diagnosis of severe endometriosis and/or adenomyosis.
- •Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results.
- •Relevant clinically significant abnormality in the results of safety laboratory tests at screening.
- •Systemic disease which might interfere with the purpose of the trial.
- •Any malignant neoplasm.
- •Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of clotting.
- •History of uncontrolled hypertension.
- •Known hypersensitivity to any component of the IP used in this trial.
- •Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg.
- •History (within 12 months) of or known current problems with alcohol or substance abuse.
- •Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
- •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.
- •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.
- •Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
研究组 & 干预措施
OXO-001 200 mg
Two tablets of 100 mg have to be taken once daily in the early morning.
干预措施: OXO-001 (Drug)
OXO-001 300 mg
Two tablets of 150 mg have to be taken once daily in the early morning.
干预措施: OXO-001 (Drug)
Placebo
Two tablets have to be taken once daily in the early morning.
干预措施: Placebo (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 10 weeks post Embryo Transfer (ET)
Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)
次要结局
- Early pregnancy loss rate(10 weeks post ET)
- Adverse events(From the first intake of the investigational product until 10 weeks post ET)
- Positive blood pregnancy test(10 to 15 days post ET)
- Hematology and biochemistry values(From the first intake of the investigational product until 10 weeks post ET)
- Vital signs(From the first intake of the investigational product until 10 weeks post ET)
- Vital pregnancy at 6 weeks(6 weeks post ET)