Clinical trial to evaluate the efficacy of progesterone given to patients with different dose by puncture than by vaginal in the preparation of the uterus finalized in medically assisted reproduction with thawed embryos

Phase 1

Conditions: Women undergoing assisted reproduction with autologous cryopreserved embryo transfer.
MedDRA version: 18.0Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2014-005474-11-IT

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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