Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-26
Brief Title:
Comparison of Two PPOS Models for Pituitary Suppression
Sponsor:
NextFertility
Organization:
NextFertility
Study Overview
Official Title:
Comparación de Dos Modelos de PPOS Para supresión Hipofisaria en Ciclos de estimulación ovárica Desogestrel vs Medroxiprogesterona
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 theres 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None