Women with polycystic ovary under a cicle of FIV/ICSI.
Conditions
Interventions
Trade Name: Fostipur
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: UROFOLLITROPIN
CAS Number: 97048-13-0
Sponsors
Institut de Recerca HSCSP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female age between 18 and 38 years (inclusive) 2. Women with a BMI under 30 kg / m2 3. Diagnosis of PCOS or polycystic ovary syndrome (according to criteria of Rotterdam) 4. Women who want pregnancy 5. basal basal FSH levels under or equal 10 IU / l 6. Infertility justify treatment with FIV / ICSI-ET 7. To be included in a protocol with GnRH antagonist 8. Presence of both ovaries and uterus able to support embryo implantation and pregnancy 9. Absence of pregnancy before starting ovarian stimulation 10. Having given written 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 164 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe male factor not allowing an FIV / ICSI with ejaculated sample 2. Patients with low ovarian reserve 3. important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney 4. HIV seropositivity 5. to have frozen embryos from previous cycles of assisted reproduction 6. undiagnosed vaginal haemorrhage 7. Poor response in previous cycles of FIV with standard stimulation protocols 8. Pregnancy, lactation or contraindication to get pregnant 9. Malformations of the sexual organs incompatible with pregnancy 10. History of allergy to gonadotrophin preparations or its excipients 11. Alcohol, drugs or psychotropic addiction 12. Concurrent participation in another study 13. Previous history of severe hyperstimulation syndrome 14. Concomitant medication that may interfere with the study medication: different hormonal treatments used in the study, other thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with inhibitors of prostaglandin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy meassure as quantity of mature oocytes respect to the total oocytes using hFSH-HP vs. hMG-HP in patients with polycystic under a FIV/ICSI cicle.;Primary end point(s): Quantity of mature oocytes respect to the total oocytes;Timepoint(s) of evaluation of this end point: 30 days; Secondary Objective: To compare both products regarding stimulation days total dose number of follicles with 16 mm diameter number of follicles with 13-15 mm diameter number of ovocytes after OPU number and quality of embryo fertilization rate embryo implantantion rate gestation rate by started cicle/punction and transference rate of living newborn abort rate cancelation rate To evaluate safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Stimulation days - total dose - number of follicles with 16 mm diameter - number of follicles with 13-15 mm diameter - number of ovocytes after OPU - number and quality of embryo - fertilization rate - embryo implantantion rate - gestation rate by started cicle/punction and transference - rate of living newborn - abort rate - cancelation rate ;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca HSCSP
Outcome results
None listed