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Late-Start Corifollitropin Alfa in Mild Ovarian Stimulation
Sponsor: Assisting Nature
Summary
This prospective randomized clinical study evaluates a novel physiology-oriented mild ovarian stimulation protocol based on the delayed initiation of corifollitropin alfa. Unlike conventional ovarian stimulation, which begins during the early follicular phase, the proposed protocol postpones exogenous gonadotropin administration until cycle day 4, allowing physiological follicular recruitment to occur before ovarian stimulation. Participants are randomly assigned to one of two strategies for prevention of premature luteinizing hormone (LH) surge: daily GnRH antagonist administration, or progesterone-primed ovarian stimulation (PPOS). The primary objective is to evaluate ovarian response and the feasibility of this simplified stimulation strategy. Secondary objectives include embryological outcomes, pregnancy outcomes, gonadotropin consumption, treatment burden, and the proportion of patients completing stimulation without supplementary gonadotropin administration. The study aims to determine whether a physiology-oriented late-start stimulation protocol can simplify IVF treatment while maintaining satisfactory embryological and clinical outcomes.
Official title: Physiology-Oriented Mild Ovarian Stimulation: A Randomized Prospective Comparison of Two Strategies for LH Suppression Using a Novel Late-Start Two-Injection Protocol Based on Delayed Initiation of Corifollitropin Alfa
Key Details
Gender
FEMALE
Age Range
28 Years - 43 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-01-01
Completion Date
2026-06-30
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
Corifollitropin Alfa 150 μg
A single subcutaneous injection of 150 μg corifollitropin alfa administered on the evening of cycle day 4 as part of a late-start mild ovarian stimulation protocol.
GnRH antagonist
Daily GnRH antagonist administration for prevention of premature LH surge according to the study protocol.
Progesterone
Oral micronized progesterone is administered daily as part of progesterone-primed ovarian stimulation for the prevention of a premature LH surge. Treatment is continued until ovulation triggering according to the predefined study protocol.
Human Menopausal Gonadotropin (hMG)
Additional hMG (150 IU/day) administered only when predefined clinical criteria are met according to the study protocol.
Locations (1)
Assisting Nature Fertility Clinic
Thessaloniki, Greece