Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure

NCT06020742 | Unknown

• 1 other identifier: RDL2022-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal to this clinical trial is to study the effectiveness and safety of automitochondrial transplantation of urine derived stem cells(USCs) in in elderly patients with low prognosis after repeated IVF failure. The main questions it aims to answer are: (1）test the effectiveness and safety of automitochondrial transplantation of urine derived stem cells (2) establish intracytoplasmic sperm injection(ICSI) mitochondrial transplantation platform Participants will be asked to:1)urine collections to further culture of autologous USCs 2)ovarian stimulation、trigger eggs、ICSI with autologous mitochondria 3）embryo transfer 4)accept pregnancy follow-up at given point

Conditions

Infertility, Female; Mitochondrial; Elderly; Assisted Reproductive Technique

Outcome Measures

Primary Outcomes (1)

• live birth rate

  Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks)

  1year after embryo transfer

Study Arms (1)

MT transfer

EXPERIMENTAL

Procedure: Autologous USC mitochondrial oocyte transplantation

Interventions

Autologous USC mitochondrial oocyte transplantation PROCEDURE

Mitochondria are isolated from urine derived stem cells from fresh middle urine of the subjects, and injected into the cytoplasm of mature oocytes together with sperm

MT transfer

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) At least 35 years old
• \) Repeated IVF failure: more than or equal to 2 egg retrieval with poor embryo quality, no transplanted embryos or failed embryo transfer (more than or equal to 4 embryos)
• \) Egg number ≤9
• \) Participate voluntarily and sign informed consent.

You may not qualify if:

• : Infertility caused by severe oligospermia, severe intrauterine adhesions, genital tract malformations, thyroid dysfunction and other endocrine, immune system, tumor and genetic diseases

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's hospital

Beijing, Beijing Municipality, China

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: September 1, 2023
• Study Start: February 9, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CN (1)