Small Molecule LCDM and GV Oocyte

April 26, 2022 updated by: Chen Xi, Peking University People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Huan Shen, Ph.D
  • Phone Number: +86 13501362063
  • Email: rmivf@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
experimental group
In the experimental group, LCDM was added to the general mature culture medium.
Other: Small molecule LCDM
The cocktail of small molecules includes four chemical components of LCDM were added to GV oocyte culture medium.
control group
In the control group, he culture medium was general mature culture medium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of GV oocyte maturation rate at 48 hours
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PKUPHIVF002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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