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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06020742

Collaborator

(none)

Enrollment

Location

Arm

22.7

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Mitochondrial Elderly Assisted Reproductive Technique	Procedure: Autologous USC mitochondrial oocyte transplantation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 9, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT transfer	Procedure: Autologous USC mitochondrial oocyte transplantation 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

Arm

Intervention/Treatment

Experimental: MT transfer

Procedure: Autologous USC mitochondrial oocyte transplantation

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

Outcome Measures

Primary Outcome Measures

live birth rate [1year after embryo transfer]
Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. At least 35 years old
1. 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)
1. Egg number ≤9
1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's hospital	Peking	Beijing	China

Sponsors and Collaborators

Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Han Hongjing, chief physician, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT06020742

Other Study ID Numbers:

RDL2022-25

First Posted:

Sep 1, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Sep 1, 2023