Comparing ovarian stimulation methods for infertility treatment
The Impact of the Intensity of Ovarian Stimulation on Embryo Quality in Predicted Suboptimal Responders. A Randomized Controlled Trial
This study is testing whether a gentler approach to ovarian stimulation during IVF can lead to better quality embryos for women struggling with infertility.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 35 Years to 40 Years |
| Sex | Female |
| Sponsor | Fundacion Dexeus Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04983173 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different intensities of ovarian stimulation on embryo quality in infertile patients undergoing in vitro fertilization (IVF). It compares a mild stimulation protocol using Clomiphene Citrate combined with rFSH against a standard rFSH stimulation protocol. The study aims to evaluate the number of good quality embryos and the early development parameters of embryos produced under these two different stimulation approaches. By assessing these outcomes, the trial seeks to determine the optimal stimulation method for improving IVF success rates in suboptimal ovarian responders.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 35 to 40 with a specific range of ovarian reserve as indicated by antral follicle count and anti-Mullerian hormone levels.
Not a fit: Patients with a higher antral follicle count, untreated autoimmune or endocrine disorders, or severe male factor infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved IVF outcomes for patients with infertility by identifying a more effective ovarian stimulation protocol.
How similar studies have performed: Previous studies have shown promising results with mild stimulation protocols in IVF, suggesting that this approach may be beneficial, although this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Barcelona
- Salud de la Mujer Dexeus — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Neves, MD — Hospital Universitari Dexeus
- 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.