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NCT06154083 | RECRUITING | Fertility

INtensity of OVarian Stimualtion and Euploid Embryos
Sponsor:

Santiago Dexeus Font Foundation

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.

Condition or disease

Fertility

Intervention/treatment

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

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

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women
Actual Study Start Date : 2023-12-12
Estimated Primary Completion Date : 2025-12-15
Estimated Study Completion Date : 2026-05-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 38 Years to 42 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
INtensity of OVarian Stimualtion and Euploid Embryos

Location Details

NCT06154083

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Spain,

University Hospital Quiron Dexeus

Barcelona, Spain, 08028