This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
On day 2 or 3 of the menstrual cycle, daily injections of 20 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
On day 2 or 3 of the menstrual cycle, daily injections of 15 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls and blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Hospital Universitario Quiron Dexeus
Barcelona, Spain
RECRUITINGNumber of euploid embryos
Number of euploid embryos
Time frame: Trough study completion, an average of 20-30 days.
Gonadotropin dose
Total gonadotropin dose used
Time frame: Up to oocyte pickup, an average of 10-20 days
Length of stimulation
Days of stimulation
Time frame: Up to oocyte pickup, an average of 10-20 days
Estradiol
Estradiol level
Time frame: Up to oocyte pickup, an average of 10-20 days
Progesterone
Progesterone level
Time frame: Up to oocyte pickup, an average of 10-20 days
LH
LH level
Time frame: Up to oocyte pickup, an average of 10-20 days
Follicular Output RaTe (FORT)
ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation
Time frame: Day one of stimulation. 1 Day
Cycle cancelation rate
Cycle cancelation rate
Time frame: Up to oocyte pickup, an average of 10-20 days
Fertilization rate
Fertilization rate
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Time frame: Up to one day after oocyte pickup, an average of 10-20 days
Time of appearance of the 2nd polar body (tPB2)
Time of appearance of the 2nd polar body (tPB2)
Time frame: Up to one day after oocyte pickup, an average of 10-20 days
Time of pronuclei disappearance (tPNf)
Time frame: Up to one day after oocyte pickup, an average of 10-20 days
Time of division from 2 to 8 cells
Time frame: Until 1, or 4 days after insemination
Time of compactation (tSC)
Time frame: Until 3, or 4 days after insemination
Time of morula (tM)
Time frame: Until 4 or 7 days after insemination
Time of cavitation (tSB)
Time frame: Until 4 or 7 days after insemination
Time of full blastulation (tB)
Time frame: Until 4 or 7 days after insemination
Total number of day 5 blastocysts
Time frame: Until 5, 6 or 7 days after insemination
Total number of good quality blastocysts
Time frame: Until 5, 6 or 7 days after insemination
Total number of embryos
Time frame: Until 5, 6 or 7 days after insemination
Blastocyst formation rate
proportion of 2PN zygotes that reach the blastocyst stage
Time frame: Until 5, 6 or 7 days after insemination
Number of embryos cryopreserved
Time frame: Until 5, 6 or 7 days after insemination
Embryo stage
Time frame: Until 5, 6 or 7 days after insemination
Clinical pregnancy rate
defined as the visualization of one or more gestational sacs
Time frame: 5-6 weeks after transfer
Ongoing pregnancy rate
defined as a viable intrauterine pregnancy
Time frame: 8-10 weeks after transfer