The Impact of the Intensity of Ovarian Stimulation on Embryo Quality in Predicted Suboptimal Responders. A Randomized Controlled Trial

FSD-IEQ-2021-03

The management of suboptimal ovarian responders remains a challenging task in IVF. These patients are frequently managed with an intense stimulation protocol of ovarian stimulation in order obtain the maximum number of embryos and, therefore, maximize the cumulative live birth rate. However, the concept of "the more the better" has been recently defied by the one of "mild stimulation". Defenders of this protocol state that with mild stimulation only the best quality oocytes are allowed to grow and, therefore, higher quality embryos will be obtained. However, the impact of the intensity of ovarian stimulation on embryo quality is far from consensual. Moreover, its effect on early embryo development has never been evaluated. Therefore, the investigators set out to perform this randomized controlled trial comparing the number of GQB and the morphokinetic parameters of early embryo development in infertile patients undergoing two different intensities of ovarian stimulation, a milder approach (CC plus 150 IU daily dose of rFSH) and a more intense approach (300 IU daily dose of rFSH).

2021-11-23

2025-12-01

2026-06-01

Recruiting

Early phase I

110

Inclusion Criteria: * Able and willing to sign the Patient Consent Form and adhere to study visitation schedule * Antral follicle count (AFC) ≥ 5 and ≤ 10 * Anti-Mullerian hormone (AMH) ≤1.5 ng/ml (AMH result of up to one year will be valid) * Age ≥ 35 years and ≤40 years * BMI ≥18.5 and \<25 kg/m2 Exclusion Criteria: * AFC \>10 * History of untreated autoimmune, endocrine or metabolic disorders * Contraindication for hormonal treatment * Preimplantation genetic diagnosis cycles * Severe male factor (sperm concentration \<5 M/mL) * Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication of being pregnant).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}

2024-03-12