Pilot clinical study multicenter, prospective, randomized, open, non-profit to evaluate the efficacy of progesterone administered with different dose subcutaneously compared to progesterone administered by Vaginal in Endometrial preparation aimed at transfer of embryos underwent previous cryopreservation - Pro.V.En

SS Centro di Fisiopatologia della Riproduzione, A.O. Papa Giovanni XXIII0 个研究点目标入组 150 人开始时间: 2015年4月29日最近更新: 2018年3月5日

试验速览

暂无简介。

•1. Women undergoing autologous transfer of embryos previously subject to cryopreservation, in cycles PMA performed for conjugal sterility, who have given their written consent to enter the study;
•2. Age 18-43;
•3. BMI <30 kg / m2;
•4. Uterine cavity normal investigated with appropriate instrumental investigation;
•5. Basal levels of plasma progesterone <3 ng / ml (at the beginning of estrogen treatment);
•6. Adequate endometrial preparation (endometrial thickness = 7 mm, E2 levels = 150 pg / ml and Progesterone <1.5 ng / ml) at the beginning of the administration of progesterone;
•7. Transfer of embryos at the blastocyst stage only;
•8. Less than 3 previous ET (in fresh or cryopreservation) with negative pregnancy.
•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 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Leiomyomas uterine intramural or submucosal impression that the uterine cavity or polyps of size> 1 cm;
•2. Endometriosis ranked III or stage IV (endometriomas);
•3. Presence of hydrosalpinx mono or bilateral;
•4. Patients suffering from diseases associated with a contraindication to deal with pregnancy;
•5. Hypersensitivity to study drugs;
•6. adrenal or thyroid dysfunction is not standardized;
•7. Any vaginal bleeding of nature to diagnose;
•8. History of arterial disease;
•9. Liver disease;
•10. Neoplasms ongoing or previous Progesterone dependent neoplasia;
•11. Cervical dysplasia of high grade;
•12. Pathology thrombophlebitic or thromboembolic in place, or a history of previous thromboembolic disease thrombophlebitic or hormone dependent;
•13. History of previous abortions, defined as three or more episodes diagnosed as clinical pregnancy (ie reflected ultrasound of gestational sac);
•14. Participation in another clinical study, also not related, in the last two months;
•15. Concomitant use of other drugs that may interfere with the results of the study

发起方

SS Centro di Fisiopatologia della Riproduzione, A.O. Papa Giovanni XXIII