Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-03-26
Brief Title:
CAPA-IVM Culture With Low Oxygen Tension
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
Official Title:
CAPA-IVM Culture With Low Oxygen Tension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Capacitation in-vitro maturation CAPA-IVM has recently been advanced in culturing oocytes from the germinal vesicle GV stage following mild or no controlled ovarian stimulation Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor HIF Nonetheless it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen O2 concentration index in the IVM culture environment has not been reached Based on the outcomes of atmospheric O2 concentration 20 and low O2 concentration 5 during CAPA-IVM culture in mice it has been hypothesized that a 5 O2 was the optimal culture condition for the pre-IVM step A 20 O2 was more suitable for the IVM culture step Therefore this study is designed to enhance the CAPA-IVM culture system improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology
Detailed Description:
Capacitation in-vitro maturation CAPA-IVM has recently been advanced in culturing oocytes from the germinal vesicle GV stage This approach is a modified version of conventional in vitro fertilization IVF and intracytoplasmic sperm injection ICSI following mild stimulation or no controlled ovarian stimulation occurred Specifically IVM can be indicated for patients diagnosed with polycystic ovary syndrome PCOS a higher number of secondary follicles constituting nearly 15 of total patients and treat a range of patients with the risks of ovarian hyperstimulation venous thromboembolism or ovarian torsion Additionally CAPA-IVM helps shorten treatment time is less expensive and upgrades patient convenience without multiple follow-up examinations The live birth rate after the first embryo transfer in the CAPA-IVM group was 352 which was not statistically significantly different from the IVF group at 432 risk difference -81 95 confidence interval from -166 to 05 However the number of high-quality embryos in each cycle and the cumulative clinical pregnancy rate in CAPA-IVM were still lower than in cIVF
Moreover further investigation should be considered due to the lack of high-quality evidence of concurrent reports Therefore improving the oocyte maturation conditions in CAPA-IVM to harvest the optimal number of oocytes and the highest possibility of embryo development is essential Many studies conducted on both animal and human models have demonstrated that the effectiveness of CAPA-IVM depends on various factors Among these the environmental culture conditions such as oxygen O2 concentration play a crucial role in producing healthy mature oocytes O2 is a vital physical and chemical component of the fallopian tube uterus and ovarian follicle it is closely related to metabolic activity oocyte maturation and early embryo development Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor HIF A consensus on the O2 concentration index in the IVM culture environment has not been reached Oocyte-embedded culture systems have been commonly used in two O2 concentrations 5 and 20 worldwide In the human body cumulus-oocyte complexes COCs mature in conditions with low O2 concentrations ranging from 2 to 9
Conversely COCs are exposed to an atmospheric O2 concentration of 20 during IVM manipulation and culture Although the concentration of 5 mimics the most proper environment in the fallopian tube and uterus the 20 O2 is widely applied in IVM techniques The use of high concentrations facilitates a better progression of differentiation processes and increases the maturation rate of oocytes However some referential frames indicated that a 20 O2 may pose a risk of reactive oxidative stress ROS leading to an imbalance in the ratio of pro-oxidants to antioxidants resulting in cellular damage Furthermore real-time respiration analysis of oocytes cultured at 5 O2 is similar to in vivo-developed oocytes but induced cellular activity and oxygen consumption at 20 O2 The impact of atmospheric O2 concentration 20 and low O2 concentration 5 during CAPA-IVM culture in mice shown in the study of Vrije Universiteit Brussel VUB - Belgium that the respiratory capability of COCs cultured at 5 O2 was relatively similar to COCs developing and maturing in vivo
Nonetheless COCs cultured at 20 O2 increased respiratory activity and oxygen consumption remarkably The study observed that pre-IVM culture of COCs at 20 O2 caused developmental disruptions Also the result was unfavorable if mouse COCs were cultured at the IVM step with 5 O2 Based on these analyses the researchers hypothesized that a 5 O2 was the optimal culture condition for the pre-IVM step while a 20 O2 was more relevant to the IVM culture step Combining these findings with results from VUB and characteristics of the differentiation process in CAPA-IVM oocytes this study is divided into two main groups including 5 pre-IVM and 20 IVM versus 20 pre-IVM and IVM and demonstrates whether this hypothesis should be applied CAPA-IVM in human The enhancement of the CAPA-IVM culture system leads to improved treatment efficiency of this technique and provides various benefits for patients undergoing assisted reproductive technology
Study procedure
Screening for eligibility
This trial will be conducted at My Duc Hospital Ho Chi Minh City Viet Nam
Women who are potentially eligible will be provided information about the trial at the time of IVM treatment indication
Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated
Patients will be provided information related to the study together with the informed consent documents Signed informed consent forms will be obtained by the investigators from all women before the enrolment
Oocytes will be divided into 2 groups
Group 1 includes 2 subgroups 1A and 1B Air Oxygen Concentration CAPA-IVM culture T Total number of oocytes after OR and there are two subgroups
The number of oocytes is divided below
If T is an even number
Number of oocytes in Group 1A One oocyte
Number of oocytes in Group 1B T1B T-22
If T is an odd number
Number of oocytes in Group 1A One oocyte
Number of oocytes in Group 1B T1B T-1-22 One oocyte remainder of the first patient will be assigned to group 1B and the remainder of the next patient will be assigned to group 2B Continuing to do so sequentially for the next remainder
Group 2 includes 2 subgroups 2A and 2B Low Oxygen Concentration CAPA- IVM culture T Total number of oocytes after OR and there are two subgroups
The number of oocytes is divided below
If T is an even number
Number of oocytes in Group 2A One oocyte
Number of oocytes in Group 2B T2B T-22
If T is an odd number
Number of oocytes in Group 2A One oocyte
Number of oocytes in Group 2B T2B T-1-22 One oocyte remainder of the first patient will be assigned to group 1B and the remainder of the next patient will be assigned to group 2B Continuing to do so sequentially for the next remainder
Group 1A 2A Collecting after capacitation oocyte and cumulus cell
Group 1B 2B Collecting after capacitation spent media blank well Collecting after maturation spent media cumulus cell blank well
Moreover further investigation should be considered due to the lack of high-quality evidence of concurrent reports Therefore improving the oocyte maturation conditions in CAPA-IVM to harvest the optimal number of oocytes and the highest possibility of embryo development is essential Many studies conducted on both animal and human models have demonstrated that the effectiveness of CAPA-IVM depends on various factors Among these the environmental culture conditions such as oxygen O2 concentration play a crucial role in producing healthy mature oocytes O2 is a vital physical and chemical component of the fallopian tube uterus and ovarian follicle it is closely related to metabolic activity oocyte maturation and early embryo development Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor HIF A consensus on the O2 concentration index in the IVM culture environment has not been reached Oocyte-embedded culture systems have been commonly used in two O2 concentrations 5 and 20 worldwide In the human body cumulus-oocyte complexes COCs mature in conditions with low O2 concentrations ranging from 2 to 9
Conversely COCs are exposed to an atmospheric O2 concentration of 20 during IVM manipulation and culture Although the concentration of 5 mimics the most proper environment in the fallopian tube and uterus the 20 O2 is widely applied in IVM techniques The use of high concentrations facilitates a better progression of differentiation processes and increases the maturation rate of oocytes However some referential frames indicated that a 20 O2 may pose a risk of reactive oxidative stress ROS leading to an imbalance in the ratio of pro-oxidants to antioxidants resulting in cellular damage Furthermore real-time respiration analysis of oocytes cultured at 5 O2 is similar to in vivo-developed oocytes but induced cellular activity and oxygen consumption at 20 O2 The impact of atmospheric O2 concentration 20 and low O2 concentration 5 during CAPA-IVM culture in mice shown in the study of Vrije Universiteit Brussel VUB - Belgium that the respiratory capability of COCs cultured at 5 O2 was relatively similar to COCs developing and maturing in vivo
Nonetheless COCs cultured at 20 O2 increased respiratory activity and oxygen consumption remarkably The study observed that pre-IVM culture of COCs at 20 O2 caused developmental disruptions Also the result was unfavorable if mouse COCs were cultured at the IVM step with 5 O2 Based on these analyses the researchers hypothesized that a 5 O2 was the optimal culture condition for the pre-IVM step while a 20 O2 was more relevant to the IVM culture step Combining these findings with results from VUB and characteristics of the differentiation process in CAPA-IVM oocytes this study is divided into two main groups including 5 pre-IVM and 20 IVM versus 20 pre-IVM and IVM and demonstrates whether this hypothesis should be applied CAPA-IVM in human The enhancement of the CAPA-IVM culture system leads to improved treatment efficiency of this technique and provides various benefits for patients undergoing assisted reproductive technology
Study procedure
Screening for eligibility
This trial will be conducted at My Duc Hospital Ho Chi Minh City Viet Nam
Women who are potentially eligible will be provided information about the trial at the time of IVM treatment indication
Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated
Patients will be provided information related to the study together with the informed consent documents Signed informed consent forms will be obtained by the investigators from all women before the enrolment
Oocytes will be divided into 2 groups
Group 1 includes 2 subgroups 1A and 1B Air Oxygen Concentration CAPA-IVM culture T Total number of oocytes after OR and there are two subgroups
The number of oocytes is divided below
If T is an even number
Number of oocytes in Group 1A One oocyte
Number of oocytes in Group 1B T1B T-22
If T is an odd number
Number of oocytes in Group 1A One oocyte
Number of oocytes in Group 1B T1B T-1-22 One oocyte remainder of the first patient will be assigned to group 1B and the remainder of the next patient will be assigned to group 2B Continuing to do so sequentially for the next remainder
Group 2 includes 2 subgroups 2A and 2B Low Oxygen Concentration CAPA- IVM culture T Total number of oocytes after OR and there are two subgroups
The number of oocytes is divided below
If T is an even number
Number of oocytes in Group 2A One oocyte
Number of oocytes in Group 2B T2B T-22
If T is an odd number
Number of oocytes in Group 2A One oocyte
Number of oocytes in Group 2B T2B T-1-22 One oocyte remainder of the first patient will be assigned to group 1B and the remainder of the next patient will be assigned to group 2B Continuing to do so sequentially for the next remainder
Group 1A 2A Collecting after capacitation oocyte and cumulus cell
Group 1B 2B Collecting after capacitation spent media blank well Collecting after maturation spent media cumulus cell blank well
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