An interventional study of The way of Cumulus-oocyte complexes (COC) CAPA-IVM culture condition in IVM and PCOS (Polycystic Ovary Syndrome), sponsored by Mỹ Đức Hospital. Completed at 1 site in Vietnam. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Mỹ Đức Hospital · Not applicable, Interventional, and Treatment
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.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
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Exclusion Criteria:
Half of COCs were cultured in the CAPA step and IVM step in a low oxygen concentration (5%) and 6% carbon dioxide at 37 degree
Other: The way of Cumulus-oocyte complexes (COC) CAPA-IVM culture condition
Half of COCs were cultured in the CAPA step and IVM step in a air oxygen concentration (20%) and 6% carbon dioxide at 37 degree
Other: The way of Cumulus-oocyte complexes (COC) CAPA-IVM culture condition
Cumulus-oocyte complexes (COC) will be cultured in CAPA-IVM 24 hrs capacitation followed by 30h maturation. The first group will be cultured in low oxygen concentration (5%Oxygen), 6% carbon dioxide at 37 degree. The second group will be cultured in air oxygen concentration (20%Oxygen), 6% carbon dioxide at 37 degree.
Number of blastocyst
Number of blastocyst obtained
Time frame: At least 5 days after intra-cytoplasmic sperm injection
Number of matured oocytes
Number of oocytes which have a polar body after maturation
Time frame: Two days after oocytes pick-up
Number of normal fertilized oocytes
Number of oocytes which have 2 pronuclear
Time frame: 16-18 hours after intra-cytoplasmic sperm injection
Number of day-3 embryos
Number of day-3 embryos obtained
Time frame: At least 3 days after intra-cytoplasmic sperm injection
Number of good-quality day-3 embryos
Number of good quality Day 3 embryos obtained
Time frame: At least 3 days after intra-cytoplasmic sperm injection
Number of good-quality blastocyst
Number of good quality blastocyst obtained
Time frame: At least 5 days after intra-cytoplasmic sperm injection
Number of vitrified blastocyst
Number of vitrified blastocyst obtained
Time frame: At least 5 days after intra-cytoplasmic sperm injection
Positive pregnancy test
Serum human chorionic gonadotropin level greater than 25 mIU/mL
Time frame: At 2 weeks after the completion of the first frozen embryo transfer
Clinical pregnancy
At least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
Time frame: 5 weeks after embryo placement after the completion of the first transfer
Ongoing pregnancy
Defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer
Time frame: At 12 weeks' gestation
Implantation rate
Defined as the number of gestational sacs per number of embryos transferred
Time frame: 3 weeks after embryo transferred after the completion of the first transfer
Multiple pregnancy
Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation)
Time frame: 5 weeks after embryo placement after the completion of the first transfer
Miscarriage
pregnancy loss at \<12 weeks
Time frame: at 12 weeks of gestation after the completion of the first transfer
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Mỹ Đức Hospital