Comparing two methods for fertility preservation in women
Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.
This study is testing two different ways to give a fertility medication to see if one method is just as good as the other for women looking to preserve their fertility.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Fundacion Dexeus Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06134479 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional trial aims to compare the effectiveness of two different administration methods of Corifollitropin alpha (CFA) for women undergoing elective fertility preservation. One group will receive a sequential two-shot CFA regimen, while the other will receive a single CFA shot followed by daily rFSH injections. The primary outcome is the number of mature oocytes retrieved, assessed under a progestin-primed ovarian stimulation protocol. The study is designed as a non-inferiority trial to determine if the sequential method is as effective as the combined approach.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 with specific ovarian reserve parameters and a BMI between 18 and 30.
Not a fit: Patients with medically indicated fertility preservation or those with conditions like PCOS or significant hormonal imbalances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and potentially less invasive method for women seeking to preserve their fertility.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results in fertility preservation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AFC ≤20 * Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid) * Between 18 and 40 years old * BMI \>18 and \<30 kg/m2 * Body weight \> 50 kg for \> 36 years * Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation. Exclusion Criteria: * Medically indicated fertility preservation * AFC \> 20 * Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria * FSH ≥ 20 * History of untreated autoimmune, endocrine or metabolic disorders * 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).
Where this trial is running
Barcelona
- Hospital Universitario Quiron Dexeus — Barcelona, Spain (Recruiting)
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.