RecruitingPhase 4NCT06154083

INtensity of OVarian Stimualtion and Euploid Embryos

The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women

Sponsor

Fundación Santiago Dexeus Font

Enrollment

110 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

Fertility

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

Sex: FEMALEMin Age: 38 YearsMax Age: 42 Years

Inclusion Criteria4

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 Criteria6

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

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Interventions

DRUGFollitropin-delta (Rekovelle) 20 mcg/day from D1

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.

DRUGFollitropin-delta (Rekovelle) 15 mcg/day from D1

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.