Small Molecule LCDM and GV Oocyte

Assisted Reproduction Clinical Trial

Official title:

Study on the Effectiveness of Small Molecule LCDM Combined With Oocyte Activation in Improving GV Oocyte in Vitro Maturation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05356429
• Other study ID #: PKUPHIVF002
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: Xi Chen, Ph.D
• Phone: +86 18600634715
• Email: chenxi[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ICSI cycle with more than 2 GV oocytes

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Assisted Reproduction

Intervention

Other:
• Small molecule LCDM
The cocktail of small molecules includes four chemical components of LCDM were added to GV oocyte culture medium.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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