Efficacy of corifolitropin alfa in double ovarian stimulation compared with two conventional ovarian stimulation cycles for embryo accmulation in low responder patients. Multicenter randomized controlled trial with non-inferiority comparison. - BOLDOS-18 (Bologna Criteria patients treated with Dual Ovarian Stimulation)

Miguel Caballero Campo0 个研究点目标入组 292 人开始时间: 2019年7月26日最近更新: 2020年2月1日

试验速览

暂无简介。

•a) Infertility requiring IVF/ICSI treatment
•b) Patients aged 36-41
•c) Body weight = 50 kg
•d) Body Mass Index between 18.5 and 34.9 kg/m2
•e) Menstrual cycles during previous four months lasting between 21 and 35 days
•f) At least two of the following three features present:
•- Previous poor ovarian reserve (less than 3 recovered oocytes)
•- Antral follicular count (AFC) lower than 7 and/or antiMüllerian hormone (AMH) less than 1.1 ng/mL
•- Any other risk factor for low ovarian response
•g) Signing of the informed consent
•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 292
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a) Age, body weight, Body Mass Index or menstrual cycles duration out of inclusion range
•b) Extreme male factor, defined as severe oligozoospermia (< 1.000.000/mL), cryptozoospermia or use of non-ejaculate spermatozoa
•c) Contraindications for IVF/ICSI or pregnancy
•d) Contraindications for use of IMP specified by EMA technical file:
•- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
•- Tumours of the ovary, breast, uterus, pituitary or hypothalamus
•- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
•- Primary ovarian failure
•- Ovarian cysts or enlarged ovaries
•- A history of Ovarian Hyperstimulation Syndrome (OHSS)
•- A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination
•- A basal antral follicle count > 20
•- Fibroid tumours of the uterus incompatible with pregnancy
•- Malformations of the reproductive organs incompatible with pregnancy
•- Polycystic ovarian syndrome (PCOS)
•e) Contraindications for use of any other drug applied in this protocol
•f) Other uterine or tubal disorders that, in investigator's opinion, might cause relevant reduction of clinical pregancy and live birth rates

发起方

Miguel Caballero Campo