The study is proposed to determine the level of compliance and pharmacoeconomic impact of three protocols for controlled ovarian stimulation in women participating in oocyte donation program
Conditions
Interventions
Trade Name: Elonva
Pharmaceutical Form: Solution for injection in pre-filled pen
Trade Name: Puregon
Pharmaceutical Form: Suspension for injection in pre-filled pen
Trade Name: Menopur
Pharmaceutica
Sponsors
IVI Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women aged 18-35 years who meet the entry criteria for the IVI Donor Program and will be receiving stimulation with gonadotropins. - Weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Woman with a basal antral follicle count above 20 or below 6 - Women with comorbidities, in the judgment of the investigator, that may interfere with the treatment of ovarian stimulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Non-inferiority study of corifollitropin alfa regarding a conventional ovarian stimulation protocol with recombinant FSH and / or HP-hMG compared to the number of oocytes retrieved and the number of metaphase II oocytes;Secondary Objective: - Comparative analysis of the fertilization and implantation rates - Comparative analysis of the drop-out rate and cycle cancellation rate - Analysis of the pharmacoeconomic impact related to the administration of a long term gonadotropin (Corifollitropin alfa) versus two daily administration of gonadotropins (FSH and recombinant HP-hMG). - Assessment of oocyte quality parameters through the following analysis: - Analysis of the hormonal profile in serum and follicular fluid - Analysis of apoptosis rate in cumulus cells;Primary end point(s): Degree of oocyte quality, defined as the number of metaphase II oocytes and the percentage of apoptosis in cumulus cells obtained at each stimulation protocols;Timepoint(s) of evaluation of this end point: A month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Length of stimulation (days) - Total dose of gonadotropins (IU) - Levels of FSH (IU) - Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation rate - Abortion rate - Cancellation rate per cycle initiated - Ovarian hyperstimulation síndrome rate - Count of adverse events;Timepoint(s) of evaluation of this end point: A month | — |
Countries
Spain
Contacts
Public ContactIVI Madrid
IVI Madrid
Outcome results
None listed