MVA to Improve the Pregnancy Outcome in Aged Infertility Women With Assisted Reproductive Technology

Sponsor
Nanjing University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05788822
Collaborator
(none)
148
1
2
37.8
3.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Mevalproic acid
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Single-center Randomized Controlled Trial on Mevalproic Acid Improving Oocyte Quality and Embryo Development in Elderly Infertile Patients
Actual Study Start Date :
Oct 8, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MVA treated group

Oocytes in this groups will be cultured with MVA

Dietary Supplement: Mevalproic acid
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

No Intervention: Control group

Oocytes in this groups will be culture without MVA

Outcome Measures

Primary Outcome Measures

  1. Embryo haploid rate [one month after oocyte retrival]

    Preimplantation genetic testing (PGT) was used to test embryo haploid rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 38 years ≤ age ≤ 42 years;

  2. Number of IVF/ICSI cycles ≤ 2

Exclusion Criteria:
  1. Egg donor cycle

  2. Chromosome abnormality;

  3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;

  4. Patients with repeated implantation failure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • Nanjing University

Investigators

  • Study Director: Haixiang Sun, MD, Center for Reproductive Medicine and Obstetrics and Gynecology, Drum Tower Hospital, Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Li-jun Ding, reseaerch fellow, Nanjing University
ClinicalTrials.gov Identifier:
NCT05788822
Other Study ID Numbers:
  • SZ-MVA-1
First Posted:
Mar 29, 2023
Last Update Posted:
Mar 29, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2023