Assisted ReproductionNCT05356429
Small Molecule LCDM and GV Oocyte
An observational study of Assisted Reproduction, run by Peking University People's Hospital.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Assisted Reproduction
- What is being tested?
- Small molecule LCDM
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- ICSI cycle with more than 2 GV oocytes
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Assisted Reproduction
- Being tested
- Small molecule LCDM
- Keywords
- Small molecule LCDM, Oocyte activation, In vitro maturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small molecule LCDMOther
The cocktail of small molecules includes four chemical components of LCDM were added to GV oocyte culture medium.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | In the experimental group, LCDM was added to the general mature culture medium. Receives: Other: Small molecule LCDM | |
| control group | In the control group, he culture medium was general mature culture medium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted ReproductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xi, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356429
- Sponsor's protocol ID
- PKUPHIVF002
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of Small Molecule LCDM Combined With Oocyte Activation in Improving GV Oocyte in Vitro Maturation
- ClinicalTrials.gov ID
- NCT05356429
- Acronym / sponsor ID
- PKUPHIVF002
- Conditions
- Assisted Reproduction
- Keywords
- Small molecule LCDM, Oocyte activation, In vitro maturation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: Small molecule LCDMIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ICSI cycle with more than 2 GV oocytes
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small molecule LCDMThe cocktail of small molecules includes four chemical components of LCDM were added to GV oocyte culture medium. | Other | experimental group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Assisted Reproduction, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Chen, Ph.D (+86 18600634715, chenxi@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of GV oocyte maturation rate at 48 hours (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.