INtensity of OVarian Stimualtion and Euploid Embryos (INOVEE)

Fundación Santiago Dexeus Font

Status and phase: Enrolling; Phase 4

Conditions: Fertility

Treatments: Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1; Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1

Study type: Interventional

Funder types: Other

Identifiers

NCT06154083

FSD-INO-2023-14

2023-507028-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 38 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Follitropin-delta 20 mcg/day from D1

Experimental group

Treatment:

Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1

Follitropin-delta 15 mcg/day from D1

Active Comparator group

Treatment:

Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1