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

NCT05788822 | Unknown

• 1 other identifier: SZ-MVA-1
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; IVF; Reproductive Disorder; Oocyte

Outcome Measures

Primary Outcomes (1)

• Embryo haploid rate

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

  one month after oocyte retrival

Study Arms (2)

MVA treated group

EXPERIMENTAL

Oocytes in this groups will be cultured with MVA

Dietary Supplement: Mevalproic acid

Control group

NO INTERVENTION

Oocytes in this groups will be culture without MVA

Interventions

Mevalproic acid 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

MVA treated group

Eligibility Criteria

• Age: 38 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years ≤ age ≤ 42 years;
• Number of IVF/ICSI cycles ≤ 2

You may not qualify if:

• Egg donor cycle
• Chromosome abnormality;
• Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
• Patients with repeated implantation failure

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Haixiang Sun, MD

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

  STUDY DIRECTOR

Central Study Contacts

Haixiang Sun, MD

CONTACT

025-83106666; haixiang_sun@nju.edu.cn

Jie Mei, MD

CONTACT

meijie560@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: reseaerch fellow

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 29, 2023
• Study Start: October 8, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)