Evaluating ovarian stimulation intensity and its effect on embryo quality in older women
The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women
This study tests if using a milder or stronger ovarian stimulation helps older women produce healthy embryos during fertility treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 38 Years to 42 Years |
| Sex | Female |
| Sponsor | Fundacion Dexeus Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06154083 on ClinicalTrials.gov |
What this trial studies
This randomized trial aims to determine whether a milder or more intense ovarian stimulation approach affects the number of euploid embryos and their morphokinetic parameters in older women undergoing preimplantation genetic testing for aneuploidy (PGT-A). Participants will receive either 20 mcg or 15 mcg of Follitropin-delta daily from day one of their cycle. The study is designed as a no-inferiority trial, meaning it seeks to show that the milder approach is not worse than the more intense one in terms of outcomes. The trial focuses on women of advanced reproductive age who are seeking fertility treatment.
Who should consider this trial
Good fit: Ideal candidates are infertile women aged 35 and older with a specific range of AMH levels seeking IVF with preimplantation genetic screening.
Not a fit: Patients with severe male factor infertility or those with contraindications to hormonal treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing ovarian stimulation protocols to improve embryo quality for older women undergoing IVF.
How similar studies have performed: While there have been studies on ovarian stimulation intensity, this specific approach in older women undergoing PGT-A is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona
- Hospital Universitario Quiron Dexeus — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Nikolaos P Polyzos, MD, PhD
- Email: nikpol@dexeus.com
- Phone: 0034932274700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.