Low response to ovarian stimulation
Conditions
Interventions
Trade Name: Elonva
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CORIFOLLITROPIN ALFA
CAS Number: 195962-23-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentra
Sponsors
IVI Sevilla
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included in this trial when: -They must go through at least two stimulation cycles. -They are low responders to ovarian stimulation according to the Bologna criteria. -They accept voluntarily to participate in the trial signing an informed consent form. According to the Bologna criteria, at least two of the following three features must be present to be considered low responder: (i) Advanced maternal age (?40 years) or any other risk factor for poor response; (ii) A previous poor response (?3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. Antral Follicular Count 5?7 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Not fullfilling the inclusion criteria. -Not being able to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect on the number of mature oocytes obtained after the follicular puncture depending on the stimulation protocol applied: -Stimulation protocol A (experimental): controlled ovarian stimulation using corifollitropin alfa -Stimulation protocol B (control): controlled ovarian stimulation using recombinant FSH and highly purified HMG;Secondary Objective: To evaluate the following parameters depending on the stimulation protocol applied (stimulation protocol A vs stimulation protocol B): - Total number of oocytes obtained after the follicular puncture - Number of stimulation days - Number of subcutaneous injection days - Total gonadotropin doses - Symptomatology - Patient perception of the stimulation treatment;Primary end point(s): Number of mature oocytes obtained after the follicular puncture;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year (from September 2013 to September 2014). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Total number of oocytes obtained after the follicular puncture -Number of stimulation days -Number of subcutaneous injection days -Total gonadotropin doses -Symptomatology -Patient perception of the estimulation protocol;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year (from September 2013 to September 2014). | — |
Countries
Spain
Contacts
Public ContactResearch associate
IVI Sevilla
Outcome results
None listed