INtensity of OVarian Stimualtion and Euploid Embryos

Last updated: February 25, 2025
Sponsor: Fundación Santiago Dexeus Font
Overall Status: Active - Recruiting

Phase

4

Condition

Reproductive Health

Treatment

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

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

Clinical Study ID

NCT06154083
FSD-INO-2023-14
2023-507028-22
  • Ages 38-42
  • Female

Study 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

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

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 significantconcurrent medical condition that could compromise subject safety or interfered withthe trial assessment).

  • Monogenic disease to be detected with PGT-M

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Follitropin-delta (Rekovelle) 15 mcg/day from D1
Phase: 4
Study Start date:
December 12, 2023
Estimated Completion Date:
May 15, 2026

Connect with a study center

  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028
    Spain

    Active - Recruiting

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