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

Primary Purpose

Infertility, Female, Mitochondrial, Elderly

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Autologous USC mitochondrial oocyte transplantation
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 1) At least 35 years old 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) Egg number ≤9 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

Sites / Locations

  • Peking University People's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MT transfer

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 31, 2023
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06020742
Brief Title
Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure
Acronym
ACTILB
Official Title
Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Mitochondrial, Elderly, Assisted Reproductive Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT transfer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous USC mitochondrial oocyte transplantation
Intervention Description
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
Primary Outcome Measure Information:
Title
live birth rate
Description
Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks)
Time Frame
1year after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) At least 35 years old 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) Egg number ≤9 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
Facility Information:
Facility Name
Peking University People's hospital
City
Peking
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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