A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference - Nvt

Organon Nederland bv0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•-Females of couples with an indication for COS and IVF or ICSI;
•- >18 and <36 years of age at the time of signing informed consent;
•-Body weight > 60 and < 90 kg and BMI > 18 and < 32 kg/m2;
•-Normal menstrual cycle length: 24-35 days;
•-Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
•-Subjects who received at least one dose of either Org 36286 or Puregon/Follistim in trial 38819
•-Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in trial 38819
•-Subjects from whom embryos have been cryopreserved in trial 38819 of which at least one embryo is thawed for use in a subsequent FTET cycle.

•-More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
•-Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
•-Presence of unilateral or bilateral hydrosalphinx (visible on USS);
•-Presence of any clinically relevant pathology affecting the uterine cavity or fibroids
•-More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
•-History of non- or low ovarian response to FSH/hMG treatment;
•-History of recurrent miscarriage (3 or more, even when unexplained);
•-FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
•-Previous use of Org 36286;
•-Use of hormonal preparations within 1 month prior to randomization;

发起方

Organon Nederland bv