The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.
This is a multicenter, randomized, controlled clinical study comparing two different progestogens for pituitary suppression in normo-responding patients undergoing controlled ovarian hyperstimulation (COH) for egg donation. Patients will be recruited on the day they begin the egg donation program. Before inclusion, patients must meet all inclusion and exclusion criteria and provide written informed consent. Each patient will be assigned a patient code based on the treatment group they are included in. Treatment with the assigned progestogens will start on the first day of COH. The standard protocol for egg donation will be followed, including stimulation with FSHr (Puregon®), pituitary suppression with either Medroxyprogesterone acetate (Progevera®) or Desogestrel (Cerazet®), and trigger with GnRH agonist (Triptorelin acetate, Decapeptyl®) 36 hours before oocyte retrieval. Patients will continue taking the assigned progestogen throughout the COH period. Oocyte quality will be assessed based on maturity and morphology, with mature oocytes classified as normal or good quality and abnormal oocytes categorized into intracytoplasmic and extracytoplasmic abnormalities. Quality assessment will be performed by two blinded embryologists.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
210
Comparation of the utilization of two distinct progestogens for pituitary suppression
NextFertility
Valencia, Valencia, Spain
Total number of oocytes retrieved from follicular puncture
The total number of oocytes retrieved from the follicular puncture shall be counted.
Time frame: 5 months
Number of mature oocytes (MII) retrieved from follicular puncture
The number of mature oocytes (MII) recovered from the follicular puncture shall be counted.
Time frame: 5 months
Oocyte quality variables
Oocyte morphology will be assessed following the standard grading system established in Next Fertility, according to the criteria mentioned above.
Time frame: 5 months
Ovarian sensitivity index (OSI
total dose of gonadotrophin used/total number of MII oocytes obtained) x 1000
Time frame: 5 months
Follicles
Number of basal antral follicles of each size at the time of starting COH, Total number of follicles on the day of the second control and Number of follicles at the time of administering the trigger.
Time frame: 5 months
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