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NCT06020742 Clinical Trial

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

Infertility, Female Clinical Trial

— ACTILB  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06020742
Other study ID # RDL2022-25
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 9, 2023
Est. completion date December 31, 2024

Study information
Verified date August 2023
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 35 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Peking University People's hospital Peking Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary live birth rate Live birth rate per embryo transfer cycle (defined as live delivery after ?28 weeks) 1year after embryo transfer
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