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 sites292 target enrollmentJuly 26, 2019

Overview

No summary available.

Registry

who.int

Start Date

July 26, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Miguel Caballero Campo

•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

•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)