Clinical trial NCT06154083: INtensity of OVarian Stimualtion and Euploid Embryos
Official title: The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Fertility
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 110
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Infertile patients with indication for IVF
* Undergoing preimplantation genetic screening cycles
* AMH \>= 1.5 ng/ml and \< 3.5 ng/ml (AMH result of up to one year will be valid)
* BMI 18.5 - 30 Kg/m2

Exclusion Criteria:

* Severe male factor requiring TESE (testicular sperm extraction)
* AMH \< 1.5 ng/ml or \>= 3.5 ng/ml
* Administration of any other drug potentially interfering with the treatment
* Contraindication for hormonal treatment
* Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
* Monogenic disease to be detected with PGT-M

Primary outcomes:
measure: Number of euploid embryos
timeFrame: Trough study completion, an average of 20-30 days.
Secondary outcomes:
measure: Gonadotropin dose
timeFrame: Up to oocyte pickup, an average of 10-20 days
measure: Length of stimulation
timeFrame: Up to oocyte pickup, an average of 10-20 days
measure: Estradiol
timeFrame: Up to oocyte pickup, an average of 10-20 days
measure: Progesterone
timeFrame: Up to oocyte pickup, an average of 10-20 days
measure: LH
timeFrame: Up to oocyte pickup, an average of 10-20 days
measure: Follicular Output RaTe (FORT)
timeFrame: Day one of stimulation. 1 Day
measure: Cycle cancelation rate
timeFrame: Up to oocyte pickup, an average of 10-20 days
measure: Fertilization rate
timeFrame: Up to one day after oocyte pickup, an average of 10-20 days
measure: Time of appearance of the 2nd polar body (tPB2)
timeFrame: Up to one day after oocyte pickup, an average of 10-20 days
measure: Time of pronuclei disappearance (tPNf)
timeFrame: Up to one day after oocyte pickup, an average of 10-20 days
measure: Time of division from 2 to 8 cells
timeFrame: Until 1, or 4 days after insemination
measure: Time of compactation (tSC)
timeFrame: Until 3, or 4 days after insemination
measure: Time of morula (tM)
timeFrame: Until 4 or 7 days after insemination
measure: Time of cavitation (tSB)
timeFrame: Until 4 or 7 days after insemination
measure: Time of full blastulation (tB)
timeFrame: Until 4 or 7 days after insemination
measure: Total number of day 5 blastocysts
timeFrame: Until 5, 6 or 7 days after insemination
measure: Total number of good quality blastocysts
timeFrame: Until 5, 6 or 7 days after insemination
measure: Total number of embryos
timeFrame: Until 5, 6 or 7 days after insemination
measure: Blastocyst formation rate
timeFrame: Until 5, 6 or 7 days after insemination
measure: Number of embryos cryopreserved
timeFrame: Until 5, 6 or 7 days after insemination
measure: Embryo stage
timeFrame: Until 5, 6 or 7 days after insemination
measure: Clinical pregnancy rate
timeFrame: 5-6 weeks after transfer
measure: Ongoing pregnancy rate
timeFrame: 8-10 weeks after transfer
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron Dexeus
Study officials:
References:
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citation: Neves AR, Montoya-Botero P, Sachs-Guedj N, Polyzos NP. Association between the number of oocytes and cumulative live birth rate: A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Mar;87:102307. doi: 10.1016/j.bpobgyn.2022.102307. Epub 2022 Dec 27.
citation: Polyzos NP, Drakopoulos P, Parra J, Pellicer A, Santos-Ribeiro S, Tournaye H, Bosch E, Garcia-Velasco J. Cumulative live birth rates according to the number of oocytes retrieved after the first ovarian stimulation for in vitro fertilization/intracytoplasmic sperm injection: a multicenter multinational analysis including approximately 15,000 women. Fertil Steril. 2018 Sep;110(4):661-670.e1. doi: 10.1016/j.fertnstert.2018.04.039.
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