A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.
IVI Barcelona
Barcelona, Barcelona, Spain
IVI Madrid
Madrid, Madrid, Spain
IVI Sevilla
Seville, Seville, Spain
IVI Valencia
Valencia, Valencia, Spain
Number of mature oocytes (metaphase II)
Number of mature oocytes (metaphase II) obtained after the follicle puncture
Time frame: 1 year
Total number of oocytes
Total number of oocytes obtained after the follicle puncture
Time frame: 1 year
Symptoms associated with the ovarian stimulation protocol
Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain.
Time frame: 1 year
Patient perception of the stimulation treatment
Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length.
Time frame: 1 year
Length of the stimulation treatment
Days of stimulation treatment
Time frame: 1 year
Number of subcutaneous injections
Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)
Time frame: 1 year
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