CompletedPhase 3

Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.

Spain194 participantsStarted 2023-12-12

Plain-language summary

This randomized was designed as non-inferiority trial aiming to compare the number of MII oocytes with 2-shot of Corifollitropin alpha (CFA) sequential administration: 150μg at stimulation day (SD) 1 and 100μg at SD 5 and 1-shot of CFA administration 150μg at SD 1 following by rFSH 200IU daily from SD 8 in women undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Number of MII oocytes retrieved

Timeframe: Trough study completion, an average of 10-20 days.

Trial details

NCT IDNCT06134479

SponsorFundación Santiago Dexeus Font

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-09

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