Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) versus Vaginal Progesterone Gel (Crinone?) for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF).

IBSA Institut Biochimique SA0 个研究点目标入组 672 人开始时间: 2008年6月23日最近更新: 2012年8月7日

适应症

试验速览

暂无简介。

•-Age 18- 42 (upon starting COH);
•-BMI <30 kg/m2;
•-<3 prior ART cycles (IVF, ICSI and related procedures);
•-Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
•-Normal uterine cavity as per recent hysterosalpingogram, sonohystogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
•-At least 3 retrieved oocytes;
•-Patient has given written 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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
•-Stage III or IV endometriosis (endometriomas);
•-Hydrosalpinx;
•-History of past poor response to COH resulting in canceling ART;
•-Use of thawed/donated oocytes;
•-Use of thawed/donated embryos;
•-Patients affected by pathologies associated with any contraindication of being pregnant;
•-Hypersensitivity to study medication;
•-Uncontrolled adrenal or thyroid dysfunction;
•-Undiagnosed vaginal bleeding;
•-History of arterial disease;
•-Patients with hepatic impairment;
•-Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
•-High grade cervical dysplasia;
•-History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS;
•-Participation in a concurrent clinical trial or another trial within the past 2 months;
•-Use of concomitant medications that might interfere with the study evaluation;
•-Pre-implantation genetic diagnosis/screening
•- Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.

发起方