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Clinical trial

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

ID
Name
FSD-INO-2023-14
Description
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.
Trial arms
Trial start
2023-12-12
Estimated PCD
2025-12-15
Trial end
2026-05-15
Status
Recruiting
Phase
Early phase I
Treatment
Follitropin-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.
Arms:
Follitropin-delta 20 mcg/day from D1
Follitropin-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.
Arms:
Follitropin-delta 15 mcg/day from D1
Size
110
Primary endpoint
Number of euploid embryos
Trough study completion, an average of 20-30 days.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-12-13

1 organization

1 product

1 indication

Organization
Fundación Santiago Dexeus Font
Product
Follitropin-delta
Indication
Fertility