A proof of concept, randomized, controlled clinical trial to assess the efficacy of subcutaneous progesterone (Prolutex) versus vaginal proges-terone (Progeffik) for endometrial preparation in women undergoing Frozen Embryo Transfer (FET) cycles. - PROGEX Study

IBSA, Institut Biochimique, S.A.0 个研究点目标入组 212 人开始时间: 2019年1月18日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
•18-37 years of age for subjects undergoing ET with autologous oocytes (both inclu-sive);
•BMI <32 kg/m2;
•Adequate endometrium preparation (Endometrial thickness > 7 mm) and E2 levels (>100 pg/ml) on the day progesterone treatment is started;
•P4 levels <1.5 ng/ml on the day progesterone treatment is started;
•Transfer of 1 or 2 frozen embryos at blastocyst stage;
•Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
•Semen from ejaculation either from the partner or from a bank;
•= 3 previous ET (frozen and fresh) with no pregnancy;
•Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).
•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 212
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Presence of functional follicles > 10 mm of diameter on the day progesterone treatment is started;
•Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
•Stage III or IV endometriosis (endometriomas);
•Hydrosalpinx;
•Pregnancy or lactation;
•Malformations of the sexual organs incompatible with pregnancy;
•Subjects affected by pathologies associated with any contraindication of being preg-nant;
•Known allergy to progesterone preparations or their excipients;
•Uncontrolled adrenal or thyroid dysfunction;
•Undiagnosed vaginal haemorrhage;
•History of, or current arterial disease;
•Subjects with hepatic impairment;
•Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus seropositive;
•Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
•High grade cervical dysplasia;
•Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
•Currently dependent on alcohol, drugs or psychotropic drugs;
•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: hor-monal treatments other than those used in the study, except thyroid hormones.

发起方

IBSA, Institut Biochimique, S.A.