Fertility Disorders, Infertility, Female
Conditions
Keywords
Primed-progestin ovarian stimulation protocol, Quality of oocytes, Oocyte yield, Ovarian Sensitivty Index, Controlled ovarian hyperstimulation
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.
Interventions
DRUGCerazet
Comparation of the utilization of two distinct progestogens for pituitary suppression
Sponsors
SINAE SL
NextFertility
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of oocytes retrieved from follicular puncture | 5 months | The total number of oocytes retrieved from the follicular puncture shall be counted. |
| Number of mature oocytes (MII) retrieved from follicular puncture | 5 months | The number of mature oocytes (MII) recovered from the follicular puncture shall be counted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte quality variables | 5 months | Oocyte morphology will be assessed following the standard grading system established in Next Fertility, according to the criteria mentioned above. |
| Ovarian sensitivity index (OSI | 5 months | total dose of gonadotrophin used/total number of MII oocytes obtained) x 1000 |
| Follicles | 5 months | 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. |
Countries
Spain
Contacts
Primary ContactLuis Quintero
Outcome results
None listed