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

Not Applicable

• Conditions: Infertility, Female; Assisted Reproductive Technique; Mitochondrial; Elderly
• Interventions: Procedure: Autologous USC mitochondrial oocyte transplantation

• Registration Number: NCT06020742
• Lead Sponsor: Peking University People's Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Status Verified: 2023-08
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. 1. At least 35 years old
2. 2. 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)
3. 3. Egg number ≤9
4. 4. Participate voluntarily and sign informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT transfer	Autologous USC mitochondrial oocyte transplantation	-

Primary Outcome Measures

Name	Time	Method
live birth rate	1year after embryo transfer	Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks)

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Peking, Beijing, China