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

NCT ID: NCT05788822

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-08
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MVA treated group

Oocytes in this groups will be cultured with MVA

Group Type: EXPERIMENTAL

Mevalproic acid

Intervention Type: DIETARY_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

Control group

Oocytes in this groups will be culture without MVA

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University

OTHER

Sponsor Role: lead

Responsible Party

Li-jun Ding

reseaerch fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haixiang Sun, MD

Role: STUDY_DIRECTOR

Center for Reproductive Medicine and Obstetrics and Gynecology, Drum Tower Hospital, Nanjing University Medical School

Locations

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haixiang Sun, MD

Role: CONTACT

haixiang_sun@nju.edu.cn

025-83106666

Jie Mei, MD

Role: CONTACT

meijie560@163.com

Facility Contacts

Haixiang Sun

Role: primary

stevensunz@163.com

025-83107188

Other Identifiers

SZ-MVA-1

Identifier Type: -

Identifier Source: org_study_id