Clinical trial NCT06304220: Comparison of Two PPOS Models for Pituitary Suppression
Official title: Comparación de Dos Modelos de PPOS Para supresión Hipofisaria en Ciclos de estimulación ovárica, Desogestrel vs Medroxiprogesterona
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility, Female
Fertility Disorders
Keywords: Primed-progestin ovarian stimulation protocol
Quality of oocytes
Oocyte yield
Ovarian Sensitivty Index
Controlled ovarian hyperstimulation
Lead sponsor: NextFertility
Sponsor class: INDUSTRY
Collaborators: name: SINAE SL
First posted: 2024-03-12
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI of 18-29,9 kg/m2
* Ultrasound count of antral follicles prior to COH ≥ 12 follicles
* Meeting the criteria for inclusion in the egg donation program
* Normal karyotype and no active sexually transmitted diseases
* No use of combined hormonal contraceptives one month before COH

Exclusion Criteria:

* Patients excluded from the egg donation program
* Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV
* Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis.
* Oligomenorrhea (\<1 menstrual cycle in 3 months)
* Use of combined hormonal contraceptives before COH

Primary outcomes:
measure: Total number of oocytes retrieved from follicular puncture
timeFrame: 5 months
measure: Number of mature oocytes (MII) retrieved from follicular puncture
timeFrame: 5 months
Secondary outcomes:
measure: Oocyte quality variables
timeFrame: 5 months
measure: Ovarian sensitivity index (OSI
timeFrame: 5 months
measure: Follicles
timeFrame: 5 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: NextFertility
state: Comunidad Valenciana
Study officials:
affiliation: NextFertility
name: Luis Quintero
role: STUDY_CHAIR
References:
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