Infertility, FemaleNCT05788822
MVA to Improve the Pregnancy Outcome in Aged Infertility Women With Assisted Reproductive Technology
A study testing Mevalproic acid in people with Infertility, Female and IVF, run by Nanjing University at 1 site in China.
Trial summary
The goal of this clinical trial is to test MVA on improving pregnancy outcome in elderly infertile patients undergoing invitro fertilization (IVF). The main question it aims to answer is whether MVA could improve embryo haploid rate. Read more about this study
- Who is it for?
- Ages 38 to 42 years, women only
- Conditions the study is for
- Infertility, Female, IVF, Reproductive Disorder
- What is being tested?
- Mevalproic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2022to Dec 2025
- Phase
- Interventional
- 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 38 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 38 years ≤ age ≤ 42 years;
- Number of IVF/ICSI cycles ≤ 2
Who cannot join
- Egg donor cycle
- Chromosome abnormality;
- Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
- Patients with repeated implantation failure
Trial locations and contacts
1 site in 1 country.
Jie Mei, MD contact
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Haixiang Sun, 025-83107188, stevensunz@163.com
About this study
Official title: A Single-center Randomized Controlled Trial on Mevalproic Acid Improving Oocyte Quality and Embryo Development in Elderly Infertile Patients
The goal of this clinical trial is to test MVA on improving pregnancy outcome in elderly infertile patients undergoing invitro fertilization (IVF). The main question it aims to answer is whether MVA could improve embryo haploid rate. Participants requested IVF are asked to randomly culture equal numbers of oocyte and embryo with or without MVA. Therefore, sibling oocytes were randomly divided into test group and control group.
Read the detailed description
After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study co compare different treatment methods on the embryo development. Sibling eggs were randomly divided into test group and control group. Specific method of randomization: all the eggs of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were cultured with MVA, while the control oocytes were cultured without MVA. Thus, half of the eggs from each elderly infertile patient were treated with MVA.
- Conditions
- Infertility, Female, IVF, Reproductive Disorder, Oocyte
- Being tested
- Mevalproic acid
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mevalproic acidDietary supplement
Methovalerate pathway is a metabolism of cholesterol and isoprenoid synthesized from acetyl coenzyme A Pathway, which plays a key role in human health and disease, is also necessary for human cells to maintain normal functions. There are a series of important metabolic intermediates in the mevalproate pathway, such as farnesyl diphosphate and incense Folyl vanillin diphosphates, which modify proteins through isoprene, play an important role in regulating cell function. In addition, the latest research shows that valproic acid, the key metabolic intermediate of valproic acid pathway, being the synthetic precursor of cholesterol and isoprene, it can activate insulin growth factor (IGF)1-R and mTOR signals and maintain cell function by mediating histone function
| Study group | Role | What they receive |
|---|---|---|
| MVA treated group | Experimental | Oocytes in this groups will be cultured with MVA Receives: Dietary Supplement: Mevalproic acid |
| Control group | No intervention | Oocytes in this groups will be culture without MVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo haploid rate
Preimplantation genetic testing (PGT) was used to test embryo haploid rate
Measured: one month after oocyte retrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start8 Oct 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
- Investigators
- Haixiang Sun, MD, Study director, Center for Reproductive Medicine and Obstetrics and Gynecology, Drum Tower Hospital, Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788822
- Sponsor's protocol ID
- SZ-MVA-1
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang S, Zhang Y, Wang L, Fang J, Ye X, Sun Y, Sun H. Mevalonate supplementation to enhance euploid embryo formation in women of advanced maternal age: a study protocol for a randomized controlled trial. Trials. 2026 Feb 14;27(1):223. doi: 10.1186/s13063-026-09522-9.
PubMed 41689053
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Trial on Mevalproic Acid Improving Oocyte Quality and Embryo Development in Elderly Infertile Patients
- ClinicalTrials.gov ID
- NCT05788822
- Acronym / sponsor ID
- SZ-MVA-1
- Conditions
- Infertility, Female, IVF, Reproductive Disorder, Oocyte
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Mar 2023 (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.
The goal of this clinical trial is to test MVA on improving pregnancy outcome in elderly infertile patients undergoing invitro fertilization (IVF). The main question it aims to answer is whether MVA could improve embryo haploid rate. Participants requested IVF are asked to randomly culture equal numbers of oocyte and embryo with or without MVA. Therefore, sibling oocytes were randomly divided into test group and control group.
Detailed description
After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study co compare different treatment methods on the embryo development. Sibling eggs were randomly divided into test group and control group. Specific method of randomization: all the eggs of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were cultured with MVA, while the control oocytes were cultured without MVA. Thus, half of the eggs from each elderly infertile patient were treated with MVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVA treated group | Experimental | Dietary Supplement: Mevalproic acidOocytes in this groups will be cultured with MVA |
| Control group | No intervention | –Oocytes in this groups will be culture without MVA |
Who may qualify
- Ages
- 38 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 38 years ≤ age ≤ 42 years;
- Number of IVF/ICSI cycles ≤ 2
Key exclusion criteria (4 listed)
- Egg donor cycle
- Chromosome abnormality;
- Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
- Patients with repeated implantation failure
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 |
|---|---|---|
| Mevalproic acidMethovalerate pathway is a metabolism of cholesterol and isoprenoid synthesized from acetyl coenzyme A Pathway, which plays a key role in human health and disease, is also necessary for human cells to maintain normal functions. There are a series of important metabolic intermediates in the mevalproate pathway, such as farnesyl diphosphate and incense Folyl vanillin diphosphates, which modify proteins through isoprene, play an important role in regulating cell function. In addition, the latest research shows that valproic acid, the key metabolic intermediate of valproic acid pathway, being the synthetic precursor of cholesterol and isoprene, it can activate insulin growth factor (IGF)1-R and mTOR signals and maintain cell function by mediating histone function | Dietary supplement | MVA treated group |
Primary outcome
Embryo haploid rate
Time frame: one month after oocyte retrival
Preimplantation genetic testing (PGT) was used to test embryo haploid rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 41689053Wang S, Zhang Y, Wang L, Fang J, Ye X, Sun Y, Sun H. Mevalonate supplementation to enhance euploid embryo formation in women of advanced maternal age: a study protocol for a randomized controlled trial. Trials. 2026 Feb 14;27(1):223. doi: 10.1186/s13063-026-09522-9.
- Individual participant dataSharing planned: No
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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.
Jie Mei, MD contact
Haixiang Sun, MD study director
Center for Reproductive Medicine and Obstetrics and Gynecology, Drum Tower Hospital, Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mevalproic acid in people with Infertility, Female and IVF, run by Nanjing University at 1 site in China.
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 2 inclusion and 4 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Haixiang Sun, MD (025-83106666, haixiang_sun@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo haploid rate (time frame: one month after oocyte retrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788822, which also lists 1 linked publication.
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 29 Mar 2023.