To evaluate the effect of random-start of ovarian stimulation initiated in the early follicular or luteal phase on the pharmacokinetics and follicular dynamics and embryo euploidy rates in oocyte donors treated with identical ovarian stimulation protocols with corifollitropin alfa and GnRH antagonist pituitary downregulation
The scope of the current prospective trial is to investigate whether Luteal Stimulation (LS) results in equivalent euploid embryos with Follicular Stimulation (FS) in young reproductive age women. The use of the "oocyte donor model" allows extrapolation of the results and application of LS routinely not only in healthy women undergoing fertility preservation but also in all patients irrespective of the menstrual date. This may indeed allow widespread introduction of LS in IVF programs which may result in proper scheduling of ovarian stimulation which is a major issue in everyday clinical practice. Given that the pharmacokinetics and follicular dynamics of 150μg corifollitropin alfa for luteal stimulation has never been evaluated, the current study of luteal stimulation with corifollitropin alfa could be very interesting for several reasons: 1. Potentially immediate synchronization of oocyte donors with recipients aiming to fresh oocyte donation. 2. Fertility preservation patients for medical, oncological and non-medical indication 3. Any situation in which endometrial receptivity is not pursued.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)
GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)
Consultorio Dexeus
Barcelona, Spain
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, Spain
Mean number of euploid embryos
Number of euploid embryos between oocytes received from follicular phase or luteal phase initiation of ovarian stimulation.
Time frame: 15-45 days following oocyte retrieval procedure
Number of oocytes
The outcome will be evaluated on the day of oocyte retrieval
Time frame: 9 -20 days from initiation of ovarian stimulation
Number of MIIs
The outcome will be evaluated on the day of oocyte retrieval
Time frame: 9 -20 days from initiation of ovarian stimulation
Total additional dose of rFSH (IU)
Addition total units of FSH following corifollitropin alfa.The outcome will be evaluated on the day of final oocyte maturation
Time frame: 9 -20 days from initiation of ovarian stimulation
Duration of ovarian stimulation
Total days of ovarian stimulation .The outcome will be evaluated on the day of final oocyte maturation
Time frame: 9 -20 days from initiation of ovarian stimulation
Endocrine profile at specific intervals
Estradiol, LH, FSH, Progesterone
Time frame: Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15)
Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation
Clinical pregnancy rates , presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity
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Time frame: 5-8 weeks after embryo transfer procedure