A Randomised, Double-blind, Parallel Groups, Placebo-controlled, Multi-centre Study Assessing the Effects of a Selective Oxytocin Antagonist (Barusiban) and a Mixed Oxytocin Antagonist - Vasopressin V1a Antagonist (Atosiban) Administered Intravenously on Luteal Phase Uterine Contractions in Oocyte Donors Supplemented With Vaginal Progesterone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- Frequency of uterine contractions
研究概览
简要总结
The main purpose of this clinical research trial was to evaluate the effects of barusiban and atosiban compared to placebo on luteal phase uterine contractions in oocyte donors supplemented with progesterone.
详细描述
This was a randomised, double-blind, parallel groups, placebo-controlled, multi-centre trial. It was designed to evaluate the effects of a selective oxytocin antagonist (barusiban) and a mixed oxytocin antagonist - vasopressin V1a antagonist (atosiban) on uterine contractions during the luteal phase. Participants in this trial were oocyte donors who had undergone controlled ovarian hyperstimulation in the long gonadotrophin-releasing hormone (GnRH) agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, received hCG for triggering of final follicular maturation and undergone oocyte retrieval (OR). The duration of the trial was five days and participants attended the clinic on three occasions: Day OR +1 (screening), Day OR +2 (randomisation and dosing of investigational medicinal product), and Day OR +5 (end-of-trial).
After screening on Day OR +1, participants initiated luteal support supplementation with vaginal progesterone, which continued throughout the trial. On Day OR +2, participants were randomised to either barusiban, atosiban or placebo and participants received an intravenous (IV) bolus followed by an IV infusion of either barusiban, atosiban or placebo for approximately 4h. A mock embryo transfer was performed 3h after start of dosing.
Uterine contractility parameters were assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation
Definitions:
The frequency of uterine contractions was defined as the number of uterine contractions per minute. A contraction was defined as one sequential upward and downward vertical displacement of the endometrial / myometrial interface over time.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Barusiban
干预措施: Barusiban (Drug)
Atosiban
干预措施: Atosiban (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of uterine contractions
时间窗: 3h after start of dosing
次要结局
- Period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions(3h after start of dosing)
- Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions(30 min and 1h post-dosing and on Day OR +5)
- Inter-subendometrial space(5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, 2h 30 min, and 3h after start of dosing, at 5 min, 30 min, and 1h after mock embryo transfer, at 30 min and 1h post-dosing and on Day OR +5)
- Pharmacokinetic parameters of barusiban and atosiban(2 days after oocyte retrieval (Day OR +2, sampling throughout the day) and 5 days after oocyte retrieval (Day OR +5, one sampling))
- Population pharmacokinetic / pharmacodynamic model(30 min and 3h after start of dosing)