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

Peking University

Status: Invitation-only

Conditions: Assisted Reproductive Technique; Mitochondrial; Elderly; Infertility, Female

Treatments: Procedure: Autologous USC mitochondrial oocyte transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06020742

RDL2022-25

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

MT transfer

Experimental group

Treatment:

Procedure: Autologous USC mitochondrial oocyte transplantation