EUCTR2021-001399-40-FR招募中1 期
Amlodipine interest in HRT (Hormone Replacement Therapy) cycle for frozen embryo transfer in the uterine pulsatility indices correction: double-blind randomized controlled trial - AmlodIP
niversity hospital of Montpellier0 个研究点目标入组 70 人开始时间: 2021年4月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Female patient ,
- •Patient scheduled for a blastocyst-type frozen embryo transfer (vitrification on D5) on cycle with hormone replacement therapy.
- •Measurement of the two uterine PIs greater than 3 (>) during the first monitoring at Dm (corresponding to D13-D16 of the cycle).
- •18 years (=) age (=) 38 years.
- •BMI = 30 kg / m2.
- •Carrying out a transfer test qualified as easy (passage of the cervix with a flexible or rigid catheter, without anesthesia or Pozzi forceps).
- •Collection and signature of free and informed consent.
- •Affiliation or beneficiary of a health insurance plan.
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient actively smokes tobacco (at least one cigarette per day at the time of inclusion in the study).
- •The patient is receiving oocytes.
- •A preimplantation diagnosis is planned for this patient.
- •The patient has stage 3 or 4 endometriosis, or adenomyosis.
- •The patient has a contraindication to the use of amlodipine (recent myocardial infarction of less than one month, severe angina pectoris, severe hepatic impairment, taking ciclosporin, low blood pressure, hypersensitivity to amlodipine, dihydropyridine derivatives).
- •Concomitant intake of CYP3A4 inhibitors or enzyme inducers
- •The patient is already being treated for high blood pressure.
- •The patient has a recruited ovarian follicle (> 12mm) during the first monitoring (the most conservative case).
- •The patient is participating in another interventional study on the human person.
- •The patient is in an exclusion period determined by a previous study.
- •The patient has already participated in this study.
- •The patient is under the protection of justice, under guardianship or curatorship.
- •It is impossible to give the patient informed information.
- •It turns out to be impossible to carry out monitoring with an experienced sonographer.
- •Lactating patient according to article L1121-5 of the CSP
- •Patient protected or unable to give consent according to article L1121-8 of the Public Health Code (CSP).
- •Vulnerable person according to article L1121-6 of the CSP.
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