Automitochondrial Transplantation Improves Live Birth in... | NCT06020742

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Aug 3, 2023

First Submission Date that Met QC Criteria

Aug 31, 2023

First Posted Date

Sep 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2023

Last Update Posted Date

Sep 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Han Hongjing, chief physician, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MT transfer	Experimental		Procedure: Autologous USC mitochondrial oocyte transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's hospital		Beijing	Beijing Municipality		China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D007246	Infertility