NCT06154083 INtensity of OVarian Stimualtion and Euploid Embryos
| NCT ID | NCT06154083 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundación Santiago Dexeus Font |
| Condition | Fertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2023-12-12 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06154083 clinical trial?
This trial is open to female participants only, aged 38 Years or older, up to 42 Years, studying Fertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06154083 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06154083 currently recruiting?
Yes, NCT06154083 is actively recruiting participants. Contact the research team at nikpol@dexeus.com for enrollment information.
Where is the NCT06154083 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06154083 clinical trial?
NCT06154083 is sponsored by Fundación Santiago Dexeus Font. The trial plans to enroll 110 participants.