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临床试验/EUCTR2021-001399-40-FR
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.

研究者

发起方
niversity hospital of Montpellier

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