Small Molecule LCDM and GV Oocyte
Study on the Effectiveness of Small Molecule LCDM Combined With Oocyte Activation in Improving GV Oocyte in Vitro Maturation
1 other identifier
observational
250
0 countries
N/A
Brief Summary
Immature eggs obtained during the oocyte retrieval cycle are discarded as medical waste because they cannot complete fertilization, but each egg is important for people with poor clinical outcome. In vitro maturation (IVM) technique allows immature GV and MI eggs to mature in vitro, offering hope for this population to increase the clinical pregnancy rate in a single oocyte retrieval cycle. However, the clinical effectiveness of IVM clinical application is still very low, especially the utilization rate of GV eggs is extremely low. The cocktail of small molecules includes four chemical components of LCDM, which are related to cell proliferation, in vitro maturation of eggs, and protection of cells from oxidative stress. Our preliminary experiments confirmed that the addition of a certain concentration of LCDM in the culture medium can significantly improve the in vitro maturation rate and embryo utilization rate of immature GV eggs. In this study, LCDM immature oocyte culture system was used to carry out in vitro maturation culture of GV oocytes, and combined with oocyte activation technology to verify the clinical safety of LCDM in vitro culture system by observing the in vitro maturation rate, fertilization rate and embryo development results of GV oocytes, so as to provide laboratory data for clinical application of GV oocytes in special patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 2, 2022
April 1, 2022
1.4 years
April 26, 2022
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of GV oocyte maturation rate at 48 hours
The GV oocyte maturation rate was defined as the number of MII oocytes which were come from GV oocyte during in vitro maturation. The more MII oocytes, the higher the in vitro maturation rate of the patient's oocytes.
48 hours
Change from the quality of MII oocytes between the two groups at 48 hours
The two groups of mature MII eggs were compared, and the chromosome ploidy, spindle integrity and cortical particle distribution were observed respectively to determine the quality of MII eggs in the two groups. The evaluation methods include that the chromosomes of normal mature oocytes are aneuploid, the spindles are arranged orderly, and the cortical particles are distributed in the cortical area.
48 hours
Study Arms (2)
experimental group
In the experimental group, LCDM was added to the general mature culture medium.
control group
In the control group, he culture medium was general mature culture medium.
Interventions
The cocktail of small molecules includes four chemical components of LCDM were added to GV oocyte culture medium.
Eligibility Criteria
GV oocytes were collected for IVM patients undergoing in vitro fertilization embryo transfer (IVF-ET) in our center. IVM combined with artificial oocyte activity was used to observe and accurately estimate the state of oocyte, then select MII oocyte for the further experiment. All patients in this study were ICSI cycle that the number of oocytes more than two GV oocytes.
You may qualify if:
- ICSI cycle with more than 2 GV oocytes
You may not qualify if:
- The etiological diagnosis is that the man has extremely severe oligoasthenospermia and primary azoospermia. These patients can lead to low fertilization rate due to sperm, so they are excluded from the group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Researcher
Study Record Dates
First Submitted
April 26, 2022
First Posted
May 2, 2022
Study Start
May 1, 2022
Primary Completion
October 1, 2023
Study Completion
December 31, 2023
Last Updated
May 2, 2022
Record last verified: 2022-04