Women undergoing assisted reproduction with autologous cryopreserved embryo transfer. MedDRA version: 18.0 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Pleyris
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PROGESTERONE
CAS Number: 57-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
USS Centro di Fisiopatologia della Riproduzione, A.O. Papa Giovanni XXIII
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the percentage of pregnancies obtained with the subcutaneous route of administration and vaginal progesterone in endometrial preparation cycle transfer of embryos underwent previous cryopreservation.;Secondary Objective: not applicable;Primary end point(s): Pregnancy rate: sonographic visualization of at least one room with gestational cardiac activity not before 4-5 weeks of starting therapy with progesterone;Timepoint(s) of evaluation of this end point: Not before 4-5 weeks of starting therapy with progesterone up to a maximum of 10 weeks of starting therapy with progesterone | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Rate of system (number of rooms gestational displayed not before 4-5 weeks of starting therapy with progesterone) / number of embryos transferred); - ?hCG positive (14 ± 2 days after ET); - Early abortion rate (number of patients with abortion occurred within 10 weeks of starting therapy with progesterone / No. of patients with clinical pregnancy ascertained); - Incidence and severity of vaginal bleeding occurring, before the serological test for pregnancy. The severity will be evaluated in case of slight spotting, moderate in case of necessity of use of absorbent, severe in the presence of menstruation. Safety: - Adverse events; - Interrupt and motivation.;Timepoint(s) of evaluation of this end point: Not before 4-5 weeks of starting therapy with progesterone up to a maximum of 10 weeks of starting therapy with progesterone | — |
Countries
Italy
Contacts
Public ContactBiogenesi
Istituti Clinici Zucchi
Outcome results
None listed