Clinical Trials Logo

Clinical Trial Summary

IVM with a pre-maturation step, known as capacitation IVM (CAPA-IVM), has demonstrated enhanced maturation of human oocytes in vitro and successful live births. However, CAPA-IVM has shown lower rates of embryo formation when compared to conventional in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ICSI) cycles. To optimize the CAPA-IVM culture system, this pilot study aims to evaluate the impact of low oxygen versus air oxygen concentrations on embryological outcomes in PCOS patients.


Clinical Trial Description

Oocyte in vitro maturation (IVM) is an alternative approach to assisted reproductive technology (ART) that has the advantage of minimal stimulation, resulting in reduced hormone-related side effects and risks, especially in women with polycystic ovary syndrome (PCOS). Oocytes retrieved for IVM procedures are derived from a diverse pool of follicles with an average diameter of between 2 and 10mm and are characterized by variable cellular and molecular attributes that indicate their immature status. Therefore, the development of an IVM culture system that could enable and enhance the acquisition and synchronization of meiotic and developmental competence prior to the meiotic resumption is essential for optimizing human IVM protocols. IVM with a pre-maturation step, known as capacitation IVM (CAPA-IVM), has been shown to improve the competence of human oocytes matured in vitro and result in live births. The pre-maturation culture of CAPA-IVM utilizes C-type natriuretic peptide (CNP), and maturation takes place in the presence of amphiregulin (AREG), both of which are physiological compounds that have been shown to prevent spontaneous meiotic resumption of oocytes (CNP) and enhance oocyte competence (AREG) during IVM. To date, the results of pilot studies have shown that CAPA-IVM increases the rates of oocyte maturation, good-quality embryos on day 3 and good-quality blastocysts, resulting in a result, a higher embryo yield was obtained compared with standard IVM. Additionally, the reported cumulative live birth rate after use of CAPA-IVM, and its non-inferiority to the cumulative live birth rate with standard in vitro fertilization highlight the clinical utility and potential of this approach. Improvements in the culture system could make CAPA-IVM more effective, but these need to be investigated. The oxygen concentration during the IVM process plays a crucial role in oocyte maturation. The use of oxygen concentrations higher than physiological levels can lead to cell damage and affect embryo development. Recent studies in mice have suggested using lower oxygen concentrations to improve IVM outcomes. However, the effectiveness of using lower oxygen concentrations in human IVM remains unproven. Therefore, this pilot study aims to compare the effectiveness of lower oxygen concentration conditions versus air oxygen in CAPA-IVM on embryology outcomes in PCOS women. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06087354
Study type Interventional
Source M? Ð?c Hospital
Contact
Status Completed
Phase N/A
Start date November 9, 2023
Completion date May 22, 2024

See also
  Status Clinical Trial Phase
Completed NCT04562883 - Single vs. Group CAPA-IVM Culture of Cumulus-oocyte Complexes N/A
Terminated NCT05793931 - A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage
Completed NCT04297553 - Fresh Versus Freeze-only After CAPA IVM on PCOS Patients N/A
Recruiting NCT04774432 - Effect of GM-CSF on CAPA-IVM System Success Rates in PCOS N/A
Completed NCT04296357 - Health of IVF Versus IVM Children (FM-BABIES)
Completed NCT04488211 - IVM Survey Among Reproductive Medicine Specialists
Completed NCT03405701 - IVM Versus IVF in High Antral Follicle Count Patients N/A
Completed NCT04048486 - Children Born From IVM-CAPA vs IVF or Natural Conception
Completed NCT03915054 - Amphiregulin Versus Non-Amphiregulin Supplementation to Maturation Culturing Medium in IVM. N/A
Recruiting NCT06369415 - Health of Babies Born From IVF Versus IVM at 5 Years Old