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Recruiting Phase 4 NCT06154083

INtensity of OVarian Stimualtion and Euploid Embryos

Trial Parameters

Condition Fertility
Sponsor Fundación Santiago Dexeus Font
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 110
Sex FEMALE
Min Age 38 Years
Max Age 42 Years
Start Date 2023-12-12
Completion 2025-12-15
Interventions
Follitropin-delta (Rekovelle) 20 mcg/day from D1Follitropin-delta (Rekovelle) 15 mcg/day from D1

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

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